PreDiabetes, Prehypertension
Conditions
Keywords
Prediabetes, Prehypertension, Variability of blood pressure, ABPM, Dapagliflozin, SGLT2
Brief summary
Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM). Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively. The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment. The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis of prediabetes and prehypertension without treatment. They will be assigned randomly two groups of 15 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks. There will be calculated body mass index (BMI) and blood pressure variability. This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will be used for differences inter-group Mann-Whitney U Test and coefficient of variation, Wilcoxon Test and index of variability for the within-groups differences. It will be considered statistical significance p ≤0.05.
Interventions
DRUGDapagliflozin
10 mg, one per day before breakfast during 12 weeks.
DRUGPlacebo - Cap
one per day before breakfast during 12 weeks.
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent signed * Patients both sexes, age between 30 and 60 years * Diagnosis of prediabetes according American Diabetes Association criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%) * Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood pressure between 120-139/ 80-89 mmHg.
Exclusion criteria
* Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Hypersensibility to ingredients of intervention * Physical impossibility for taking pills * Known uncontrolled renal, hepatic, heart or thyroid diseased * Diabetes diagnosis * Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL * Total cholesterol ≥240 mg/dL * History of cardiovascular disease * Worker per shift / night
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Daytime Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3 |
| Nighttime Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 |
| Systolic Blood Pressure Weighted Standard Deviation at Week 12 | Week 12 | Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Diastolic Blood Pressure Weighted Standard Deviation at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 |
| Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 |
| Average Real Variability of Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Average Real Variability of Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Nighttime Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3 |
| 24-hours Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| 24-hours Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3 |
| Daytime Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index at Week 12 | Week 12 | Body Mas Index was calculated with the Quetelet index formula |
| Office Systolic Blood Pressure at Week 12 | Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) |
| Office of Diastolic Blood Pressure at Week 12 | Week 12 | Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.) |
| Fasting Plasma Glucose Levels at Week 12 | Week 12 | The fasting glucose levels was evaluated with enzymatic/colorimetric techniques |
| 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 | Week 12 | 2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique |
| Glycated Hemoglobin A1c (A1C) at Week 12 | Week 12 | A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) |
| Daytime Mean Arterial Pressure at Week 12 | Week 12 | The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 |
| Nighttime Mean Arterial Pressure at Week 12 | Week 12 | The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3 |
| Daytime Hypertensive Load at Week 12 | Week 12 | The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3 |
| Nocturnal Hypertensive Load at Week 12 | Week 12 | The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3 |
| Number of Participants With Prediabetes at Week 12 | Week 12 | Prediabetes was diagnosed with the criteria of the American Diabetes Association. |
| Number of Participants With Prehypertension at Week 12 | Week 12 | Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee. |
| Number of Participants With Prediabetes Plus Prehypertension at Week 12 | Week 12 | Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension. |
| Body Weight at Week 12 | Week 12 | The body weight was measured with a bioimpedance balance |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapagliflozin Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. | 15 |
| Placebo Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap: one per day before breakfast during 12 weeks. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Dapagliflozin | Placebo |
|---|---|---|---|
| 24-hours Diastolic Blood Pressure | 73.5 mmHg STANDARD_DEVIATION 7 | 73 mmHg STANDARD_DEVIATION 7 | 74 mmHg STANDARD_DEVIATION 7 |
| 24-hours Systolic Blood pressure | 120 mmHg STANDARD_DEVIATION 8.5 | 121 mmHg STANDARD_DEVIATION 8 | 119 mmHg STANDARD_DEVIATION 9 |
| 2-hours plasma glucose after a oral glucose tolerance test | 8.15 mmol/L STANDARD_DEVIATION 1.9 | 8.4 mmol/L STANDARD_DEVIATION 1.4 | 7.9 mmol/L STANDARD_DEVIATION 2.4 |
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 6 | 47 Years STANDARD_DEVIATION 7 | 50 Years STANDARD_DEVIATION 5 |
| Average real variability of Diastolic Blood Pressure | 6.55 mmHg STANDARD_DEVIATION 1.3 | 6.5 mmHg STANDARD_DEVIATION 1.4 | 6.6 mmHg STANDARD_DEVIATION 1.2 |
| Average real variability of Systolic Blood Pressure | 9.4 mmHg STANDARD_DEVIATION 2.25 | 9.5 mmHg STANDARD_DEVIATION 2.5 | 9.3 mmHg STANDARD_DEVIATION 2 |
| Body Mass Index | 30.5 kg/m^2 STANDARD_DEVIATION 2 | 30 kg/m^2 STANDARD_DEVIATION 2 | 31 kg/m^2 STANDARD_DEVIATION 2 |
| Body weight | 77 kg STANDARD_DEVIATION 11 | 74 kg STANDARD_DEVIATION 10 | 80 kg STANDARD_DEVIATION 12 |
| Coefficient of variation of 24-hours, Diastolic Blood Pressure | 11.7 Percentage of Coefficient of variability STANDARD_DEVIATION 2.9 | 11.1 Percentage of Coefficient of variability STANDARD_DEVIATION 2.9 | 12.3 Percentage of Coefficient of variability STANDARD_DEVIATION 2.9 |
| Coefficient of variation of 24-hours, Systolic Blood Pressure | 9.05 Percentage of Coefficient of variability STANDARD_DEVIATION 1.91 | 8.9 Percentage of Coefficient of variability STANDARD_DEVIATION 2.2 | 9.2 Percentage of Coefficient of variability STANDARD_DEVIATION 3 |
| Coefficient of variation of daytime, Diastolic Blood Pressure | 9.45 Percentage of Coefficient of variability STANDARD_DEVIATION 2.8 | 8.9 Percentage of Coefficient of variability STANDARD_DEVIATION 2 | 10.0 Percentage of Coefficient of variability STANDARD_DEVIATION 3.6 |
| Coefficient of variation of daytime, Systolic Blood Pressure | 7.7 Percentage of Coefficient of variability STANDARD_DEVIATION 2.8 | 7.3 Percentage of Coefficient of variability STANDARD_DEVIATION 2.2 | 8.1 Percentage of Coefficient of variability STANDARD_DEVIATION 3.4 |
| Coefficient of variation of nighttime, Diastolic Blood Pressure | 11.4 Percentage of Coefficient of variability STANDARD_DEVIATION 4 | 10.9 Percentage of Coefficient of variability STANDARD_DEVIATION 4.2 | 11.9 Percentage of Coefficient of variability STANDARD_DEVIATION 3.8 |
| Coefficient of variation of nighttime, Systolic Blood Pressure | 8.6 Percentage of Coefficient of variability STANDARD_DEVIATION 2.7 | 8.3 Percentage of Coefficient of variability STANDARD_DEVIATION 2.1 | 8.9 Percentage of Coefficient of variability STANDARD_DEVIATION 3.3 |
| Daytime Diastolic Blood Pressure | 75.5 mmHg STANDARD_DEVIATION 7 | 75 mmHg STANDARD_DEVIATION 7 | 76 mmHg STANDARD_DEVIATION 7 |
| Daytime hypertensive load | 30.2 mmHg STANDARD_DEVIATION 26.5 | 30.7 mmHg STANDARD_DEVIATION 23.5 | 29.7 mmHg STANDARD_DEVIATION 29.5 |
| Daytime Mean Arterial Pressure | 91.5 mmHg STANDARD_DEVIATION 7.5 | 92 mmHg STANDARD_DEVIATION 7 | 91 mmHg STANDARD_DEVIATION 8 |
| Daytime Systolic Blood Pressure | 123 mmHg STANDARD_DEVIATION 9.5 | 124 mmHg STANDARD_DEVIATION 8 | 122 mmHg STANDARD_DEVIATION 11 |
| Diastolic Blood Pressure weighted Standard Deviation | 7.3 mmHg STANDARD_DEVIATION 1.9 | 6.9 mmHg STANDARD_DEVIATION 1.8 | 7.7 mmHg STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 15 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting plasma glucose | 6.15 mmol/L STANDARD_DEVIATION 0.35 | 6.3 mmol/L STANDARD_DEVIATION 0.3 | 6.0 mmol/L STANDARD_DEVIATION 0.4 |
| Glycated hemoglobin A1c (A1C) | 5.85 percentage of A1C STANDARD_DEVIATION 0.4 | 5.9 percentage of A1C STANDARD_DEVIATION 0.5 | 5.8 percentage of A1C STANDARD_DEVIATION 0.3 |
| Nightime Diastolic Blood Pressure | 68.5 mmHg STANDARD_DEVIATION 7.5 | 68 mmHg STANDARD_DEVIATION 7 | 69 mmHg STANDARD_DEVIATION 8 |
| Nightime Systolic Blood Pressure | 114 mmHg STANDARD_DEVIATION 12 | 114 mmHg STANDARD_DEVIATION 11 | 114 mmHg STANDARD_DEVIATION 13 |
| Nighttime Mean Arterial Pressure | 84.5 mmHg STANDARD_DEVIATION 8.9 | 85 mmHg STANDARD_DEVIATION 8 | 84 mmHg STANDARD_DEVIATION 9 |
| Nocturnal hypertensive load | 48.15 mmHg STANDARD_DEVIATION 32.35 | 51.1 mmHg STANDARD_DEVIATION 32.3 | 45.2 mmHg STANDARD_DEVIATION 32.4 |
| Number of Participants with a Dipper circadian blood pressure pattern | 9 Participants | 5 Participants | 4 Participants |
| Number of Participants with a Dipper reverse circadian blood pressure pattern | 4 Participants | 1 Participants | 3 Participants |
| Number of Participants with a Nondipper circadian blood pressure pattern | 17 Participants | 9 Participants | 8 Participants |
| Office Diastolic blood pressure | 80.5 mmHg STANDARD_DEVIATION 6.5 | 80.0 mmHg STANDARD_DEVIATION 6 | 81.0 mmHg STANDARD_DEVIATION 7 |
| Office Systolic blood pressure | 127 mmHg STANDARD_DEVIATION 6 | 127 mmHg STANDARD_DEVIATION 7 | 127 mmHg STANDARD_DEVIATION 5 |
| Region of Enrollment Mexico | 30 Mexico | 15 Mexico | 15 Mexico |
| Sex: Female, Male Female | 19 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 7 Participants |
| Systolic Blood Pressure weighted Standard Deviation | 9.5 mmHg STANDARD_DEVIATION 2.6 | 9.2 mmHg STANDARD_DEVIATION 1.9 | 9.8 mmHg STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
24-hours Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | 24-hours Diastolic Blood Pressure at Week 12 | 73 mmHg | Standard Deviation 8 |
| Placebo | 24-hours Diastolic Blood Pressure at Week 12 | 75 mmHg | Standard Deviation 9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.752Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.582Wilcoxon (Mann-Whitney)
Primary
24-hours Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | 24-hours Systolic Blood Pressure at Week 12 | 117 mmHg | Standard Deviation 11 |
| Placebo | 24-hours Systolic Blood Pressure at Week 12 | 120 mmHg | Standard Deviation 13 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.755Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.046Wilcoxon (Mann-Whitney)
Primary
Average Real Variability of Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Average Real Variability of Diastolic Blood Pressure at Week 12 | 6.8 mmHg | Standard Deviation 1.4 |
| Placebo | Average Real Variability of Diastolic Blood Pressure at Week 12 | 7.0 mmHg | Standard Deviation 1.1 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.087Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.345Wilcoxon (Mann-Whitney)
Primary
Average Real Variability of Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Average Real Variability of Systolic Blood Pressure at Week 12 | 10.0 mmHg | Standard Deviation 2.6 |
| Placebo | Average Real Variability of Systolic Blood Pressure at Week 12 | 9.2 mmHg | Standard Deviation 2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.944Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.65Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 | 10.2 Percentage of Coefficient of variability | Standard Deviation 4.2 |
| Placebo | Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 | 9.2 Percentage of Coefficient of variability | Standard Deviation 3.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.507Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 | 7.7 Percentage of Coefficient of variability | Standard Deviation 2.4 |
| Placebo | Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 | 8.4 Percentage of Coefficient of variability | Standard Deviation 2.6 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.814Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.463Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 | 12.3 Percentage of Coefficient of variability | Standard Deviation 4.7 |
| Placebo | Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 | 13.5 Percentage of Coefficient of variability | Standard Deviation 5 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.152Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.158Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 | 8.4 Percentage of Coefficient of variability | Standard Deviation 3.2 |
| Placebo | Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 | 10.6 Percentage of Coefficient of variability | Standard Deviation 4.1 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.152Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.972Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 | 12.3 Percentage of Coefficient of variability | Standard Deviation 4.8 |
| Placebo | Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 | 11.3 Percentage of Coefficient of variability | Standard Deviation 2.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.552Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.087Wilcoxon (Mann-Whitney)
Primary
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 | 9.9 Percentage of Coefficient of variability | Standard Deviation 3.4 |
| Placebo | Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 | 9.5 Percentage of Coefficient of variability | Standard Deviation 1.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.875Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin groupp-value: 0.196Wilcoxon (Mann-Whitney)
Primary
Daytime Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Daytime Diastolic Blood Pressure at Week 12 | 76 mmHg | Standard Deviation 9 |
| Placebo | Daytime Diastolic Blood Pressure at Week 12 | 77 mmHg | Standard Deviation 10 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.624Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 1Wilcoxon (Mann-Whitney)
Primary
Daytime Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Daytime Systolic Blood Pressure at Week 12 | 121 mmHg | Standard Deviation 11 |
| Placebo | Daytime Systolic Blood Pressure at Week 12 | 122 mmHg | Standard Deviation 14 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.814Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.22Wilcoxon (Mann-Whitney)
Primary
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Diastolic Blood Pressure Weighted Standard Deviation at Week 12 | 8.0 mmHg | Standard Deviation 3.6 |
| Placebo | Diastolic Blood Pressure Weighted Standard Deviation at Week 12 | 8.3 mmHg | Standard Deviation 2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.108Wilcoxon (Mann-Whitney)
Primary
Nighttime Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Nighttime Diastolic Blood Pressure at Week 12 | 67 mmHg | Standard Deviation 7 |
| Placebo | Nighttime Diastolic Blood Pressure at Week 12 | 72 mmHg | Standard Deviation 8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.454Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.115Wilcoxon (Mann-Whitney)
Primary
Nighttime Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Nighttime Systolic Blood Pressure at Week 12 | 108 mmHg | Standard Deviation 10 |
| Placebo | Nighttime Systolic Blood Pressure at Week 12 | 115 mmHg | Standard Deviation 11 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.906Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.017Wilcoxon (Mann-Whitney)
Primary
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 | 8 Participants |
| Placebo | Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 | 3 Participants |
Comparison: Results showed in this section are the result of the differences between change of intervention groupsp-value: 0.047Chi-squared
Primary
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 | 1 Participants |
| Placebo | Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 | 2 Participants |
Comparison: Results showed in this section are the result of the differences between change of intervention groupsp-value: 0.539Chi-squared
Primary
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 | 4 Participants |
| Placebo | Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 | 8 Participants |
Comparison: Results showed in this section are the result of the differences between change of intervention groupp-value: 0.115Chi-squared
Primary
Systolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Systolic Blood Pressure Weighted Standard Deviation at Week 12 | 9.8 mmHg | Standard Deviation 3.5 |
| Placebo | Systolic Blood Pressure Weighted Standard Deviation at Week 12 | 10.3 mmHg | Standard Deviation 2.5 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.422Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.917Wilcoxon (Mann-Whitney)
Secondary
2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 | 7.8 mmol/L | Standard Deviation 1.8 |
| Placebo | 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 | 8.3 mmol/L | Standard Deviation 2.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.701Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.081Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index at Week 12
Body Mas Index was calculated with the Quetelet index formula
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Body Mass Index at Week 12 | 28 kg/m^2 | Standard Deviation 2 |
| Placebo | Body Mass Index at Week 12 | 29 kg/m^2 | Standard Deviation 9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.814Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.011Wilcoxon (Mann-Whitney)
Secondary
Body Weight at Week 12
The body weight was measured with a bioimpedance balance
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Body Weight at Week 12 | 73 kg | Standard Deviation 10 |
| Placebo | Body Weight at Week 12 | 78 kg | Standard Deviation 12 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.844Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Daytime Hypertensive Load at Week 12
The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Daytime Hypertensive Load at Week 12 | 28.6 percentage of hypertensive load | Standard Deviation 29.8 |
| Placebo | Daytime Hypertensive Load at Week 12 | 34.1 percentage of hypertensive load | Standard Deviation 35.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.807Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.754Wilcoxon (Mann-Whitney)
Secondary
Daytime Mean Arterial Pressure at Week 12
The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Daytime Mean Arterial Pressure at Week 12 | 92 mmHg | Standard Deviation 11 |
| Placebo | Daytime Mean Arterial Pressure at Week 12 | 92 mmHg | Standard Deviation 10 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.727Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.451Wilcoxon (Mann-Whitney)
Secondary
Fasting Plasma Glucose Levels at Week 12
The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Fasting Plasma Glucose Levels at Week 12 | 5.8 mmol/L | Standard Deviation 0.5 |
| Placebo | Fasting Plasma Glucose Levels at Week 12 | 6.1 mmol/L | Standard Deviation 0.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.285Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Glycated Hemoglobin A1c (A1C) at Week 12
A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glycated Hemoglobin A1c (A1C) at Week 12 | 5.4 percentage of A1C | Standard Deviation 0.4 |
| Placebo | Glycated Hemoglobin A1c (A1C) at Week 12 | 5.9 percentage of A1C | Standard Deviation 0.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.581Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin groupp-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
Nighttime Mean Arterial Pressure at Week 12
The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Nighttime Mean Arterial Pressure at Week 12 | 84 mmHg | Standard Deviation 9 |
| Placebo | Nighttime Mean Arterial Pressure at Week 12 | 87 mmHg | Standard Deviation 9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.463Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.043Wilcoxon (Mann-Whitney)
Secondary
Nocturnal Hypertensive Load at Week 12
The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Nocturnal Hypertensive Load at Week 12 | 38.1 percentage of hypertensive load | Standard Deviation 32 |
| Placebo | Nocturnal Hypertensive Load at Week 12 | 52.0 percentage of hypertensive load | Standard Deviation 32 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.507Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.015Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Prediabetes at Week 12
Prediabetes was diagnosed with the criteria of the American Diabetes Association.
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Prediabetes at Week 12 | 7 Participants |
| Placebo | Number of Participants With Prediabetes at Week 12 | 2 Participants |
Comparison: Results showed in this section are the result of the differences between intervention groupsp-value: 0.039Fisher Exact
Secondary
Number of Participants With Prediabetes Plus Prehypertension at Week 12
Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Prediabetes Plus Prehypertension at Week 12 | 4 Participants |
| Placebo | Number of Participants With Prediabetes Plus Prehypertension at Week 12 | 0 Participants |
Comparison: Results showed in this section are the result of the differences between intervention groupsp-value: 0.096Fisher Exact
Secondary
Number of Participants With Prehypertension at Week 12
Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Number of Participants With Prehypertension at Week 12 | 7 Participants |
| Placebo | Number of Participants With Prehypertension at Week 12 | 1 Participants |
Comparison: Results showed in this section are the result of the differences between intervention groupsp-value: 0.011Fisher Exact
Secondary
Office of Diastolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Office of Diastolic Blood Pressure at Week 12 | 75 mmHg | Standard Deviation 6 |
| Placebo | Office of Diastolic Blood Pressure at Week 12 | 82 mmHg | Standard Deviation 8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.461Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.011Wilcoxon (Mann-Whitney)
Secondary
Office Systolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Time frame: Week 12
Population: Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Office Systolic Blood Pressure at Week 12 | 119 mmHg | Standard Deviation 8 |
| Placebo | Office Systolic Blood Pressure at Week 12 | 130 mmHg | Standard Deviation 7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values in placebo groupp-value: 0.221Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values in dapagliflozin groupp-value: 0.001Wilcoxon (Mann-Whitney)