Metabolic Syndrome X
Conditions
Keywords
metabolic syndrome, forxiga, dapagliflozin, insulin secretion, insulin sensitivity
Brief summary
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL). The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load. 12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months. The remaining 12 patients will receive placebo at the same dose. There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index). This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.
Interventions
DRUGDapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
DRUGPlacebo
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
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
* Patients both sexes * Age between 30 and 60 years * Metabolic Syndrome according to the IDF criteria * Waist circumference * Man ≥90 cm * Woman ≥80 cm * And two of the following criteria * High density lipoprotein * Man ≤40 mg/dL * Woman ≤50 mg/dL * Fasting glucose ≥100 mg/dL * Triglycerides ≥150 mg/dL * Blood pressure ≥130/85 mmHg * Informed consent signed
Exclusion criteria
* Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Hypersensibility to SGLT2 inhibitors * Physical impossibility for taking pills * Known uncontrolled renal, hepatic, heart or thyroid diseased * Previous treatment for the metabolic syndrome components * Body Mass Index ≥39.9 kg/m2 * Fasting glucose ≥126 mg/dL * Triglycerides ≥500 mg/dL * Total cholesterol ≥240 mg/dL * Low density lipoprotein (c-LDL) ≥190 mg/dL * Blood Pressure ≥140/90 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference at Week 12. | Week 12 | The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. |
| Triglycerides Levels at Week 12. | Week 12 | The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. |
| High Density Lipoprotein (c-HDL) Levels at Week 12. | Week 12 | The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. |
| Glucose Levels at Minute 0 at Week 12. | Week 12 | The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. |
| Systolic Blood Pressure at Week 12. | Week 12 | The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. |
| Diastolic Blood Pressure at Week 12. | Week 12 | The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. |
| Insulinogenic Index (Total Insulin Secretion) at Week 12. | Week 12 | The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12. |
| Stumvoll Index (First Phase of Insulin Secretion) at Week 12. | Week 12 | Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12. |
| Matsuda Index (Total Insulin Sensitivity) at Week 12. | Week 12 | Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of Glucose at Week 12. | Week 12 | The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 |
| AUC of Insulin at Week 12. | Week 12 | The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 |
| Glucose at Minute 30 at Week 12. | Week 12 | The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve |
| Body Weight at Week 12. | Week 12 | The weight it's going to be measured at week 12 with a bioimpedance balance. |
| Glucose at Minute 90 at Week 12. | Week 12 | The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve |
| Glucose at Minute 120 at Week 12. | Week 12 | The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve |
| Glucose at Minute 60 at Week 12. | Week 12 | The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve |
| Body Mass Index at Week 12 | Week 12 | The Body Mass index it's going to be calculated at week 12 with the Quetelet index. |
| Fat Mass at Week 12. | Week 12 | The fat mass is going to be evaluated at week 12 through bioimpedance. |
| Total Cholesterol at Week 12 | Week 12 | The total cholesterol will be estimated by standardized techniques at week 12. |
| Low Density Lipoproteins (c-LDL) at Week 12 | Week 12 | The c-LDL levels are going to be measured at week 12 with standardized techniques. |
| Alanine Aminotransferase (ALT) at Week 12. | Week 12. | The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. |
| Aspartate Aminotransferase (AST) at Week 12. | Week 12 | The hepatic transaminase AST will be evaluated with standardized methods at week 12 |
| Creatinine at Week 12. | Week 12. | The creatinine levels are going to be measured at week 12 with standardized techniques. |
| Uric Acid at Week 12. | Week 12. | The uric acid levels are going to be measured at week 12 with standardized techniques. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapagliflozin Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. | 12 |
| Placebo Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Dapagliflozin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 8.4 | 49.5 years STANDARD_DEVIATION 6 | 46.4 years STANDARD_DEVIATION 7.9 |
| Alanine aminotransferase (ALT) | 50.9 U/L STANDARD_DEVIATION 31.6 | 37.9 U/L STANDARD_DEVIATION 17.1 | 44.4 U/L STANDARD_DEVIATION 25.7 |
| Area Under the Curve (AUC) glucose (mmol*hr/L) | 1235 mmol*hr/L STANDARD_DEVIATION 304 | 1060 mmol*hr/L STANDARD_DEVIATION 233 | 1148.3 mmol*hr/L STANDARD_DEVIATION 280 |
| Area Under the Curve (AUC) insulin (pmol*hr/L) | 103910 pmol*hr/L STANDARD_DEVIATION 55167 | 106683 pmol*hr/L STANDARD_DEVIATION 41787 | 105297 pmol*hr/L STANDARD_DEVIATION 47884 |
| Aspartate aminotransferase (AST) | 37.9 U/L STANDARD_DEVIATION 19.1 | 28.8 U/L STANDARD_DEVIATION 17.7 | 33.4 U/L STANDARD_DEVIATION 18.6 |
| Body Mass Index (BMI) (kg/m^2) | 33.3 kg/m^2 STANDARD_DEVIATION 3.5 | 31.5 kg/m^2 STANDARD_DEVIATION 3.1 | 32.5 kg/m^2 STANDARD_DEVIATION 3.4 |
| Body weight (kg) | 82.7 kilograms STANDARD_DEVIATION 12.9 | 80.0 kilograms STANDARD_DEVIATION 11.3 | 81.4 kilograms STANDARD_DEVIATION 12 |
| Creatinine (mmol/L) | 0.06 mmol/L STANDARD_DEVIATION 0.02 | 0.07 mmol/L STANDARD_DEVIATION 0.02 | 0.07 mmol/L STANDARD_DEVIATION 0.02 |
| Diastolic Blood Pressure (DBP) (mmHg) | 78 mmHg STANDARD_DEVIATION 12 | 79 mmHg STANDARD_DEVIATION 10 | 78.2 mmHg STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 24 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 |
| Fat mass (kg) | 33.2 kilograms STANDARD_DEVIATION 8.5 | 32.6 kilograms STANDARD_DEVIATION 8.2 | 32.9 kilograms STANDARD_DEVIATION 8.2 |
| Glucose at minute 0 (0') (mmol/L) | 6.1 mmol/L STANDARD_DEVIATION 0.5 | 5.8 mmol/L STANDARD_DEVIATION 0.6 | 6.0 mmol/L STANDARD_DEVIATION 0.6 |
| Glucose at minute 120 (120') (mmol/L) | 8.9 mmol/L STANDARD_DEVIATION 2.1 | 7.6 mmol/L STANDARD_DEVIATION 2.2 | 8.3 mmol/L STANDARD_DEVIATION 2.2 |
| Glucose at minute 30 (30') (mmol/L) | 10.7 mmol/L STANDARD_DEVIATION 2.6 | 9.1 mmol/L STANDARD_DEVIATION 2.1 | 9.9 mmol/L STANDARD_DEVIATION 2.4 |
| Glucose at minute 60 (60') (mmol/L) | 12.0 mmol/L STANDARD_DEVIATION 3.8 | 10.4 mmol/L STANDARD_DEVIATION 2.6 | 11.2 mmol/L STANDARD_DEVIATION 3.3 |
| Glucose at minute 90 (90') (mmol/L) | 10.9 mmol/L STANDARD_DEVIATION 3.1 | 9.1 mmol/L STANDARD_DEVIATION 2.6 | 10.0 mmol/L STANDARD_DEVIATION 2.9 |
| HDL-cholesterol (mmol/L) | 1.2 mmol/L STANDARD_DEVIATION 0.2 | 1.2 mmol/L STANDARD_DEVIATION 0.3 | 1.2 mmol/L STANDARD_DEVIATION 0.3 |
| Insulinogenic index (total insulin secretion) | 0.83 index STANDARD_DEVIATION 0.64 | 0.98 index STANDARD_DEVIATION 0.46 | 0.91 index STANDARD_DEVIATION 0.55 |
| LDL-cholesterol (mmol/L) | 2.9 mmol/L STANDARD_DEVIATION 1 | 2.8 mmol/L STANDARD_DEVIATION 0.9 | 2.9 mmol/L STANDARD_DEVIATION 1 |
| Matsuda Index (insulin sensitivity) | 2.0 index STANDARD_DEVIATION 1.1 | 1.8 index STANDARD_DEVIATION 0.8 | 1.9 index STANDARD_DEVIATION 1 |
| Region of Enrollment Mexico | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
| Stumvoll Index (first phase of insulin secretion) | 1566 index STANDARD_DEVIATION 1137 | 1675 index STANDARD_DEVIATION 819 | 1620.8 index STANDARD_DEVIATION 971 |
| Systolic Blood Pressure (SBP) (mmHg) | 121 mmHg STANDARD_DEVIATION 13 | 126 mmHg STANDARD_DEVIATION 10 | 123.8 mmHg STANDARD_DEVIATION 11.9 |
| Total cholesterol (mmol/L) | 5.4 mmol/L STANDARD_DEVIATION 0.7 | 4.9 mmol/L STANDARD_DEVIATION 1 | 5.2 mmol/L STANDARD_DEVIATION 0.9 |
| Triglycerides (mmol/L) | 2.7 mmol/L STANDARD_DEVIATION 1.4 | 2.0 mmol/L STANDARD_DEVIATION 0.7 | 2.4 mmol/L STANDARD_DEVIATION 1.2 |
| Uric acid (umol/L) | 267.7 umol/L STANDARD_DEVIATION 95.2 | 315.2 umol/L STANDARD_DEVIATION 101.1 | 291.5 umol/L STANDARD_DEVIATION 101.1 |
| Waist circumference (WC) (cm) | 101.5 centimeters STANDARD_DEVIATION 10.1 | 96.1 centimeters STANDARD_DEVIATION 7.2 | 98.9 centimeters STANDARD_DEVIATION 9.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Diastolic Blood Pressure at Week 12.
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Diastolic Blood Pressure at Week 12. | 76 mmHg | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure at Week 12. | 79 mmHg | Standard Deviation 10 |
Comparison: Analysis between before and after the interventionp-value: 0.433Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.407Wilcoxon (Mann-Whitney)
Primary
Glucose Levels at Minute 0 at Week 12.
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glucose Levels at Minute 0 at Week 12. | 5.7 mmol/L | Standard Deviation 1.1 |
| Placebo | Glucose Levels at Minute 0 at Week 12. | 5.8 mmol/L | Standard Deviation 0.7 |
Comparison: Analysis between before and after the interventionp-value: 0.067Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.918Wilcoxon (Mann-Whitney)
Primary
High Density Lipoprotein (c-HDL) Levels at Week 12.
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | High Density Lipoprotein (c-HDL) Levels at Week 12. | 1.3 mmol/L | Standard Deviation 0.2 |
| Placebo | High Density Lipoprotein (c-HDL) Levels at Week 12. | 1.3 mmol/L | Standard Deviation 0.2 |
Comparison: Analysis between before and after the interventionp-value: 0.161Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.079Wilcoxon (Mann-Whitney)
Primary
Insulinogenic Index (Total Insulin Secretion) at Week 12.
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Insulinogenic Index (Total Insulin Secretion) at Week 12. | 0.35 index | Standard Deviation 0.11 |
| Placebo | Insulinogenic Index (Total Insulin Secretion) at Week 12. | 0.99 index | Standard Deviation 0.38 |
Comparison: Analysis between before and after the interventionp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.826Wilcoxon (Mann-Whitney)
Primary
Matsuda Index (Total Insulin Sensitivity) at Week 12.
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Matsuda Index (Total Insulin Sensitivity) at Week 12. | 2.7 index | Standard Deviation 1.4 |
| Placebo | Matsuda Index (Total Insulin Sensitivity) at Week 12. | 1.6 index | Standard Deviation 0.8 |
Comparison: Analysis between before and after the interventionp-value: 0.075Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.432Wilcoxon (Mann-Whitney)
Primary
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Stumvoll Index (First Phase of Insulin Secretion) at Week 12. | 1463 index | Standard Deviation 879 |
| Placebo | Stumvoll Index (First Phase of Insulin Secretion) at Week 12. | 2198 index | Standard Deviation 996 |
Comparison: Analysis between before and after the interventionp-value: 0.791Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.413Wilcoxon (Mann-Whitney)
Primary
Systolic Blood Pressure at Week 12.
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Systolic Blood Pressure at Week 12. | 117 mmHg | Standard Deviation 10 |
| Placebo | Systolic Blood Pressure at Week 12. | 121 mmHg | Standard Deviation 13 |
Comparison: Analysis between before and after the interventionp-value: 0.128Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.454Wilcoxon (Mann-Whitney)
Primary
Triglycerides Levels at Week 12.
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Triglycerides Levels at Week 12. | 1.7 mmol/L | Standard Deviation 0.8 |
| Placebo | Triglycerides Levels at Week 12. | 1.7 mmol/L | Standard Deviation 0.6 |
Comparison: Analysis between before and after the interventionp-value: 0.003Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.248Wilcoxon (Mann-Whitney)
Primary
Waist Circumference at Week 12.
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Waist Circumference at Week 12. | 97.6 centimeters | Standard Deviation 8.9 |
| Placebo | Waist Circumference at Week 12. | 97.2 centimeters | Standard Deviation 6.9 |
Comparison: Analysis between before and after the interventionp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.089Wilcoxon (Mann-Whitney)
Secondary
Alanine Aminotransferase (ALT) at Week 12.
The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques.
Time frame: Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Alanine Aminotransferase (ALT) at Week 12. | 32.1 U/L | Standard Deviation 15.9 |
| Placebo | Alanine Aminotransferase (ALT) at Week 12. | 38.1 U/L | Standard Deviation 25 |
Comparison: Analysis between before and after the interventionp-value: 0.006Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.95Wilcoxon (Mann-Whitney)
Secondary
Aspartate Aminotransferase (AST) at Week 12.
The hepatic transaminase AST will be evaluated with standardized methods at week 12
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Aspartate Aminotransferase (AST) at Week 12. | 31.1 U/L | Standard Deviation 14.5 |
| Placebo | Aspartate Aminotransferase (AST) at Week 12. | 29.5 U/L | Standard Deviation 16.5 |
Comparison: Analysis between before and after the interventionp-value: 0.011Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.454Wilcoxon (Mann-Whitney)
Secondary
AUC of Glucose at Week 12.
The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | AUC of Glucose at Week 12. | 1153 mmol*hr/L | Standard Deviation 280 |
| Placebo | AUC of Glucose at Week 12. | 1129 mmol*hr/L | Standard Deviation 232 |
Comparison: Analysis between before and after the interventionp-value: 0.129Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.365Wilcoxon (Mann-Whitney)
Secondary
AUC of Insulin at Week 12.
The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | AUC of Insulin at Week 12. | 45016 pmol*h/L | Standard Deviation 22147 |
| Placebo | AUC of Insulin at Week 12. | 119704 pmol*h/L | Standard Deviation 46872 |
Comparison: Analysis between before and after the interventionp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.175Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index at Week 12
The Body Mass index it's going to be calculated at week 12 with the Quetelet index.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Body Mass Index at Week 12 | 32.6 kg/m^2 | Standard Deviation 3.6 |
| Placebo | Body Mass Index at Week 12 | 32.1 kg/m^2 | Standard Deviation 2.7 |
Comparison: Analysis between before and after the interventionp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.778Wilcoxon (Mann-Whitney)
Secondary
Body Weight at Week 12.
The weight it's going to be measured at week 12 with a bioimpedance balance.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Body Weight at Week 12. | 81.2 kilograms | Standard Deviation 12.8 |
| Placebo | Body Weight at Week 12. | 79.6 kilograms | Standard Deviation 11.3 |
Comparison: Analysis between before and after the interventionp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.835Wilcoxon (Mann-Whitney)
Secondary
Creatinine at Week 12.
The creatinine levels are going to be measured at week 12 with standardized techniques.
Time frame: Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Creatinine at Week 12. | 0.07 mmol/L | Standard Deviation 0.01 |
| Placebo | Creatinine at Week 12. | 0.05 mmol/L | Standard Deviation 0.02 |
Comparison: Analysis between before and after the interventionp-value: 0.652Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.055Wilcoxon (Mann-Whitney)
Secondary
Fat Mass at Week 12.
The fat mass is going to be evaluated at week 12 through bioimpedance.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Fat Mass at Week 12. | 32.7 kilograms | Standard Deviation 9.2 |
| Placebo | Fat Mass at Week 12. | 34.4 kilograms | Standard Deviation 7.3 |
Comparison: Analysis between before and after the interventionp-value: 0.338Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.309Wilcoxon (Mann-Whitney)
Secondary
Glucose at Minute 120 at Week 12.
The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glucose at Minute 120 at Week 12. | 8.5 mmol/L | Standard Deviation 2.1 |
| Placebo | Glucose at Minute 120 at Week 12. | 8.8 mmol/L | Standard Deviation 2.2 |
Comparison: Analysis between before and after the interventionp-value: 0.346Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Glucose at Minute 30 at Week 12.
The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glucose at Minute 30 at Week 12. | 10.5 mmol/L | Standard Deviation 2 |
| Placebo | Glucose at Minute 30 at Week 12. | 10.0 mmol/L | Standard Deviation 1.3 |
Comparison: Analysis between before and after the interventionp-value: 0.392Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.123Wilcoxon (Mann-Whitney)
Secondary
Glucose at Minute 60 at Week 12.
The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glucose at Minute 60 at Week 12. | 11.1 mmol/L | Standard Deviation 3.1 |
| Placebo | Glucose at Minute 60 at Week 12. | 11.4 mmol/L | Standard Deviation 1.6 |
Comparison: Analysis between before and after the interventionp-value: 0.176Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.268Wilcoxon (Mann-Whitney)
Secondary
Glucose at Minute 90 at Week 12.
The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Glucose at Minute 90 at Week 12. | 9.8 mmol/L | Standard Deviation 3.5 |
| Placebo | Glucose at Minute 90 at Week 12. | 9.9 mmol/L | Standard Deviation 2.3 |
Comparison: Analysis between before and after the interventionp-value: 0.064Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.462Wilcoxon (Mann-Whitney)
Secondary
Low Density Lipoproteins (c-LDL) at Week 12
The c-LDL levels are going to be measured at week 12 with standardized techniques.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Low Density Lipoproteins (c-LDL) at Week 12 | 3.1 mmol/L | Standard Deviation 0.5 |
| Placebo | Low Density Lipoproteins (c-LDL) at Week 12 | 2.8 mmol/L | Standard Deviation 0.9 |
Comparison: Analysis between before and after the interventionp-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.206Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol at Week 12
The total cholesterol will be estimated by standardized techniques at week 12.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Total Cholesterol at Week 12 | 5.2 mmol/L | Standard Deviation 0.7 |
| Placebo | Total Cholesterol at Week 12 | 4.9 mmol/L | Standard Deviation 0.8 |
Comparison: Analysis between before and after the interventionp-value: 0.049Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.563Wilcoxon (Mann-Whitney)
Secondary
Uric Acid at Week 12.
The uric acid levels are going to be measured at week 12 with standardized techniques.
Time frame: Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapagliflozin | Uric Acid at Week 12. | 243.9 umol/L | Standard Deviation 55.3 |
| Placebo | Uric Acid at Week 12. | 339.0 umol/L | Standard Deviation 53.5 |
Comparison: Analysis between before and after the interventionp-value: 0.254Wilcoxon (Mann-Whitney)
Comparison: Analysis between before and after the interventionp-value: 0.787Wilcoxon (Mann-Whitney)