Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus type 2, Glycemic control, Propolis, Metformin, Pharmacological treatment-naïve patients
Brief summary
The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment. All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment. At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated. All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation. This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.
Interventions
DRUGPropolis
Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
DRUGMetformin
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
DRUGPlacebo
Calcined magnesium, two times per day before break-fast and dinner 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
* Patients both sexes * Age between 30 and 60 years * Mild to moderate physical activity * Stable body weight for at least 12 weeks prior to the study * BMI 25.0 - 34.9 kg/m2 * Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \>126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \>200 mg/dl * Informed consent signed
Exclusion criteria
* Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Previous treatment for glucose * Fasting glucose ≥250 mg/dL * Known uncontrolled renal, hepatic, heart or thyroid diseased * Hypersensibility to ingredients of intervention * Known allergies to bee stings or their derived products * Triglycerides ≥500 mg/dL * Total cholesterol ≥240 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Serum Glucose | Week 12 | The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 |
| 2 Hours After Oral Glucose Tolerance Test in Week 12 | Week 12 | 2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12 |
| Glycosylated Hemoglobin (A1C) | Week 12 | Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC Glucose | Week 12 | Area under the curve (AUC) of glucose was calculated with the polygonal formula. The area under the curve (AUC) of glucose, (0.5 \* glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 \* G 120´) \* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. |
| AUC Insulin | Week 12 | Area under the curve (AUC) of insulin was calculated with the polygonal formula. The area under the curve (AUC) of insulin, (0.5 \* Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 \* I 120´) \* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. |
| Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | Week 12 | The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12 |
| Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | Week 12 | The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12 |
| Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | Week 12 | The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12. |
| Waist Circumference | Week 12 | Waist circumference was evaluated at week 12 with a flexible tape |
| Body Weight | Week 12 | The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12 |
| Body Mass Index | Week 12 | Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12 |
| Percentage of Fat Mass | Week 12 | Percentage of fat mass was evaluated through bioimpedance. |
| Total Insulin Secretion | Week 12 | Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the 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 |
| Triglycerides | Week 12 | Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12 |
| High Density Lipoprotein Cholesterol (c-HDL) | Week 12 | c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 |
| Low Density Lipoproteins Cholesterol (c-LDL) | Week 12 | c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12 |
| Very Low Density Lipoprotein (c-VLDL) | Week 12 | Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. |
| Creatinine | Week 12 | Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques |
| Uric Acid | Week 12 | Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques |
| Systolic Blood Pressure | Week 12 | The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12. |
| Diastolic Blood Pressure | Week 12 | The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12. |
| Total Cholesterol | Week 12 | Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12 |
| Insulin Sensitivity | Week 12 | Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the 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 |
| First Phase of Insulin Secretion | Week 12 | The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst 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 first phase of insulin secretion |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propolis Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. | 12 |
| Metformin Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. | 12 |
| Placebo Placebo capsules, two times per day before break-fast and dinner during 12 weeks.
Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Propolis | Total | Metformin | Placebo |
|---|---|---|---|---|
| 2 hours after OGTT | 14.6 mmol/L STANDARD_DEVIATION 2.1 | 14.5 mmol/L STANDARD_DEVIATION 2.5 | 15.8 mmol/L STANDARD_DEVIATION 2.8 | 13.2 mmol/L STANDARD_DEVIATION 1.9 |
| Age, Continuous | 46 years STANDARD_DEVIATION 7 | 49 years STANDARD_DEVIATION 6 | 51 years STANDARD_DEVIATION 4 | 50 years STANDARD_DEVIATION 5 |
| AUC glucose | 965 mmol*min/L STANDARD_DEVIATION 137 | 978 mmol*min/L STANDARD_DEVIATION 133.6 | 1039 mmol*min/L STANDARD_DEVIATION 174 | 930 mmol*min/L STANDARD_DEVIATION 90 |
| AUC insulin | 52541 pmol*min/L STANDARD_DEVIATION 9165 | 50577.6 pmol*min/L STANDARD_DEVIATION 7741 | 45323 pmol*min/L STANDARD_DEVIATION 9005 | 53869 pmol*min/L STANDARD_DEVIATION 5053 |
| Body mass index | 29.0 kg/m^2 STANDARD_DEVIATION 4.4 | 29.5 kg/m^2 STANDARD_DEVIATION 3.7 | 29.1 kg/m^2 STANDARD_DEVIATION 3.7 | 30.2 kg/m^2 STANDARD_DEVIATION 3.13 |
| Body weight | 76.4 kg STANDARD_DEVIATION 11.5 | 78.6 kg STANDARD_DEVIATION 12.8 | 80.7 kg STANDARD_DEVIATION 14.4 | 78.6 kg STANDARD_DEVIATION 13.1 |
| Creatinine | 72.5 mmol/L STANDARD_DEVIATION 31.8 | 70.7 mmol/L STANDARD_DEVIATION 26.5 | 65.4 mmol/L STANDARD_DEVIATION 21.2 | 69.8 mmol/L STANDARD_DEVIATION 27.4 |
| Diastolic blood pressure | 76.5 mmHg STANDARD_DEVIATION 7.8 | 75.4 mmHg STANDARD_DEVIATION 7.2 | 76.2 mmHg STANDARD_DEVIATION 7 | 73.4 mmHg STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 36 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting serum glucose | 7.3 mmol/L STANDARD_DEVIATION 1.4 | 7.7 mmol/L STANDARD_DEVIATION 1.4 | 8.0 mmol/L STANDARD_DEVIATION 1.6 | 7.7 mmol/L STANDARD_DEVIATION 1.2 |
| First phase of insulin secretion | 2092 index STANDARD_DEVIATION 653 | 1984 index STANDARD_DEVIATION 686 | 1608 index STANDARD_DEVIATION 736 | 2221 index STANDARD_DEVIATION 566 |
| Glucose 30 min after oral glucose tolerance test | 12.4 mmol/L STANDARD_DEVIATION 2.3 | 12.7 mmol/L STANDARD_DEVIATION 2.7 | 13.7 mmol/L STANDARD_DEVIATION 3.8 | 12.0 mmol/L STANDARD_DEVIATION 1.3 |
| Glucose 60 min after oral glucose tolerance test | 15.2 mmol/L STANDARD_DEVIATION 3 | 15.6 mmol/L STANDARD_DEVIATION 2.7 | 17.2 mmol/L STANDARD_DEVIATION 2.9 | 14.7 mmol/L STANDARD_DEVIATION 1.9 |
| Glucose 90 min after oral glucose tolerance test | 14.7 mmol/L STANDARD_DEVIATION 2 | 15.5 mmol/L STANDARD_DEVIATION 2.8 | 17.5 mmol/L STANDARD_DEVIATION 2.4 | 14.3 mmol/L STANDARD_DEVIATION 2.8 |
| Glycosylated Hemoglobin (A1C) | 6.6 percentage STANDARD_DEVIATION 0.8 | 6.7 percentage STANDARD_DEVIATION 0.8 | 6.8 percentage STANDARD_DEVIATION 0.9 | 6.8 percentage STANDARD_DEVIATION 0.9 |
| High Density Lipoprotein cholesterol (c-HDL) | 1.0 mmol/L STANDARD_DEVIATION 0.3 | 0.9 mmol/L STANDARD_DEVIATION 0.2 | 0.9 mmol/L STANDARD_DEVIATION 0.3 | 0.9 mmol/L STANDARD_DEVIATION 0.2 |
| Insulin sensitivity | 1.0 index STANDARD_DEVIATION 0.4 | 1.0 index STANDARD_DEVIATION 0.3 | 1.1 index STANDARD_DEVIATION 0.3 | 0.8 index STANDARD_DEVIATION 0.3 |
| Low-Density Lipoproteins-cholesterol (c-LDL) | 3.0 mmol/L STANDARD_DEVIATION 0.8 | 3.0 mmol/L STANDARD_DEVIATION 0.7 | 3.0 mmol/L STANDARD_DEVIATION 0.8 | 2.9 mmol/L STANDARD_DEVIATION 0.5 |
| Percentage of fat mass | 32.8 % fat mass STANDARD_DEVIATION 9.7 | 32.4 % fat mass STANDARD_DEVIATION 8.2 | 30.7 % fat mass STANDARD_DEVIATION 6.8 | 33.8 % fat mass STANDARD_DEVIATION 8.3 |
| Region of Enrollment Mexico | 12 participants | 36 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 18 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 18 Participants | 5 Participants | 5 Participants |
| Systolic blood pressure | 116.9 mmHg STANDARD_DEVIATION 8.7 | 117.0 mmHg STANDARD_DEVIATION 8.8 | 118.4 mmHg STANDARD_DEVIATION 10.6 | 115.7 mmHg STANDARD_DEVIATION 7.2 |
| Total cholesterol | 5.0 mmol/L STANDARD_DEVIATION 0.8 | 4.8 mmol/L STANDARD_DEVIATION 0.8 | 4.7 mmol/L STANDARD_DEVIATION 1.1 | 4.7 mmol/L STANDARD_DEVIATION 0.5 |
| Total insulin secretion | 0.5 index STANDARD_DEVIATION 0.1 | 0.5 index STANDARD_DEVIATION 0.1 | 0.4 index STANDARD_DEVIATION 0.2 | 0.5 index STANDARD_DEVIATION 0.1 |
| Triglycerides | 2.2 mmol/L STANDARD_DEVIATION 1.1 | 2.0 mmol/L STANDARD_DEVIATION 0.9 | 1.7 mmol/L STANDARD_DEVIATION 0.6 | 2.0 mmol/L STANDARD_DEVIATION 1 |
| Uric acid | 356.9 mmol/L STANDARD_DEVIATION 71.4 | 327.1 mmol/L STANDARD_DEVIATION 77.3 | 315.2 mmol/L STANDARD_DEVIATION 65.4 | 309.2 mmol/L STANDARD_DEVIATION 89.2 |
| Very low density lipoprotein (VLDL) | 1.0 mmol/L STANDARD_DEVIATION 0.5 | 0.9 mmol/L STANDARD_DEVIATION 0.4 | 0.8 mmol/L STANDARD_DEVIATION 0.3 | 0.9 mmol/L STANDARD_DEVIATION 0.5 |
| Waist circumference | 101.2 cm STANDARD_DEVIATION 9.6 | 102.6 cm STANDARD_DEVIATION 10.3 | 103.4 cm STANDARD_DEVIATION 11.7 | 103.2 cm STANDARD_DEVIATION 10.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 3 / 12 | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
2 Hours After Oral Glucose Tolerance Test in Week 12
2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | 2 Hours After Oral Glucose Tolerance Test in Week 12 | 13.1 mmol/L | Standard Deviation 1.9 |
| Metformin | 2 Hours After Oral Glucose Tolerance Test in Week 12 | 13.7 mmol/L | Standard Deviation 2.7 |
| Placebo | 2 Hours After Oral Glucose Tolerance Test in Week 12 | 13.2 mmol/L | Standard Deviation 2.1 |
p-value: 0.963Kruskal-Wallis
Primary
Fasting Serum Glucose
The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Fasting Serum Glucose | 6.6 mmol/L | Standard Deviation 0.9 |
| Metformin | Fasting Serum Glucose | 7.3 mmol/L | Standard Deviation 1.1 |
| Placebo | Fasting Serum Glucose | 8.2 mmol/L | Standard Deviation 1.7 |
p-value: 0.031Kruskal-Wallis
Primary
Glycosylated Hemoglobin (A1C)
Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Glycosylated Hemoglobin (A1C) | 6.3 % of A1C | Standard Deviation 0.9 |
| Metformin | Glycosylated Hemoglobin (A1C) | 6.6 % of A1C | Standard Deviation 0.8 |
| Placebo | Glycosylated Hemoglobin (A1C) | 7.0 % of A1C | Standard Deviation 1 |
p-value: 0.236Kruskal-Wallis
Secondary
AUC Glucose
Area under the curve (AUC) of glucose was calculated with the polygonal formula. The area under the curve (AUC) of glucose, (0.5 \* glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 \* G 120´) \* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | AUC Glucose | 921 mmol*min/L | Standard Deviation 126 |
| Metformin | AUC Glucose | 967 mmol*min/L | Standard Deviation 116 |
| Placebo | AUC Glucose | 939 mmol*min/L | Standard Deviation 126.4 |
p-value: 0.686Kruskal-Wallis
Secondary
AUC Insulin
Area under the curve (AUC) of insulin was calculated with the polygonal formula. The area under the curve (AUC) of insulin, (0.5 \* Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 \* I 120´) \* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | AUC Insulin | 44123 pmol*min/L | Standard Deviation 13381 |
| Metformin | AUC Insulin | 27603 pmol*min/L | Standard Deviation 15935 |
| Placebo | AUC Insulin | 51287 pmol*min/L | Standard Deviation 7440 |
p-value: 0.004Kruskal-Wallis
Secondary
Body Mass Index
Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Body Mass Index | 28.6 kg/m2 | Standard Deviation 4.3 |
| Metformin | Body Mass Index | 29.2 kg/m2 | Standard Deviation 3.8 |
| Placebo | Body Mass Index | 30.0 kg/m2 | Standard Deviation 2.9 |
p-value: 0.668Kruskal-Wallis
Secondary
Body Weight
The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Body Weight | 75.3 kg | Standard Deviation 11.3 |
| Metformin | Body Weight | 81.0 kg | Standard Deviation 15.2 |
| Placebo | Body Weight | 77.8 kg | Standard Deviation 13.5 |
p-value: 0.697Kruskal-Wallis
Secondary
Creatinine
Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Creatinine | 55.7 mmol/L | Standard Deviation 10.6 |
| Metformin | Creatinine | 74.2 mmol/L | Standard Deviation 16.8 |
| Placebo | Creatinine | 63.6 mmol/L | Standard Deviation 26.5 |
p-value: 0.059Kruskal-Wallis
Secondary
Diastolic Blood Pressure
The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 (MEDIAN) | Dispersion |
|---|---|---|---|
| Propolis | Diastolic Blood Pressure | 74.8 mmHg | Standard Deviation 7.4 |
| Metformin | Diastolic Blood Pressure | 74.4 mmHg | Standard Deviation 7.9 |
| Placebo | Diastolic Blood Pressure | 72.3 mmHg | Standard Deviation 3.8 |
p-value: 0.551Kruskal-Wallis
Secondary
First Phase of Insulin Secretion
The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst 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 first phase of insulin secretion
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | First Phase of Insulin Secretion | 1346 index | Standard Deviation 784 |
| Metformin | First Phase of Insulin Secretion | 996 index | Standard Deviation 742 |
| Placebo | First Phase of Insulin Secretion | 1652 index | Standard Deviation 863 |
p-value: 0.162Kruskal-Wallis
Secondary
Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | 12.3 mmol/L | Standard Deviation 2 |
| Metformin | Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | 12.5 mmol/L | Standard Deviation 2.1 |
| Placebo | Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | 12.0 mmol/L | Standard Deviation 1.8 |
p-value: 0.945Kruskal-Wallis
Secondary
Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | 15.1 mmol/L | Standard Deviation 2.8 |
| Metformin | Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | 15.9 mmol/L | Standard Deviation 2.5 |
| Placebo | Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | 14.2 mmol/L | Standard Deviation 2.6 |
p-value: 0.332Kruskal-Wallis
Secondary
Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | 14.2 mmol/L | Standard Deviation 2.6 |
| Metformin | Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | 16.6 mmol/L | Standard Deviation 2.1 |
| Placebo | Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | 14.9 mmol/L | Standard Deviation 2.9 |
p-value: 0.075Kruskal-Wallis
Secondary
High Density Lipoprotein Cholesterol (c-HDL)
c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | High Density Lipoprotein Cholesterol (c-HDL) | 1.0 mmol/L | Standard Deviation 0.3 |
| Metformin | High Density Lipoprotein Cholesterol (c-HDL) | 0.9 mmol/L | Standard Deviation 0.2 |
| Placebo | High Density Lipoprotein Cholesterol (c-HDL) | 0.9 mmol/L | Standard Deviation 0.1 |
p-value: 0.376Kruskal-Wallis
Secondary
Insulin Sensitivity
Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the 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
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Insulin Sensitivity | 1.5 index | Standard Deviation 0.6 |
| Metformin | Insulin Sensitivity | 1.8 index | Standard Deviation 1 |
| Placebo | Insulin Sensitivity | 1.0 index | Standard Deviation 0.5 |
p-value: 0.017Kruskal-Wallis
Secondary
Low Density Lipoproteins Cholesterol (c-LDL)
c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Low Density Lipoproteins Cholesterol (c-LDL) | 3.1 mmol/L | Standard Deviation 0.5 |
| Metformin | Low Density Lipoproteins Cholesterol (c-LDL) | 2.7 mmol/L | Standard Deviation 0.5 |
| Placebo | Low Density Lipoproteins Cholesterol (c-LDL) | 3.0 mmol/L | Standard Deviation 0.5 |
p-value: 0.21Kruskal-Wallis
Secondary
Percentage of Fat Mass
Percentage of fat mass was evaluated through bioimpedance.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Percentage of Fat Mass | 32.8 % of fat mass | Standard Deviation 10.3 |
| Metformin | Percentage of Fat Mass | 28.4 % of fat mass | Standard Deviation 6.8 |
| Placebo | Percentage of Fat Mass | 33.6 % of fat mass | Standard Deviation 8.2 |
p-value: 0.308Kruskal-Wallis
Secondary
Systolic Blood Pressure
The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Systolic Blood Pressure | 114.6 mmHg | Standard Deviation 7.4 |
| Metformin | Systolic Blood Pressure | 119.2 mmHg | Standard Deviation 11.4 |
| Placebo | Systolic Blood Pressure | 112.8 mmHg | Standard Deviation 6.4 |
p-value: 0.122Kruskal-Wallis
Secondary
Total Cholesterol
Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Total Cholesterol | 5.1 mmol/L | Standard Deviation 0.7 |
| Metformin | Total Cholesterol | 4.6 mmol/L | Standard Deviation 0.9 |
| Placebo | Total Cholesterol | 4.7 mmol/L | Standard Deviation 0.7 |
p-value: 0.318Kruskal-Wallis
Secondary
Total Insulin Secretion
Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the 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
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Total Insulin Secretion | 0.5 index | Standard Deviation 0.2 |
| Metformin | Total Insulin Secretion | 0.3 index | Standard Deviation 0.2 |
| Placebo | Total Insulin Secretion | 0.5 index | Standard Deviation 0.2 |
p-value: 0.015Kruskal-Wallis
Secondary
Triglycerides
Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Triglycerides | 2.0 mmol/L | Standard Deviation 0.8 |
| Metformin | Triglycerides | 2.0 mmol/L | Standard Deviation 1 |
| Placebo | Triglycerides | 1.9 mmol/L | Standard Deviation 0.8 |
p-value: 0.88Kruskal-Wallis
Secondary
Uric Acid
Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Uric Acid | 339.0 mmol/L | Standard Deviation 77.3 |
| Metformin | Uric Acid | 327.1 mmol/L | Standard Deviation 71.4 |
| Placebo | Uric Acid | 333.1 mmol/L | Standard Deviation 95.2 |
p-value: 0.978Kruskal-Wallis
Secondary
Very Low Density Lipoprotein (c-VLDL)
Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Very Low Density Lipoprotein (c-VLDL) | 0.9 mmol/L | Standard Deviation 0.4 |
| Metformin | Very Low Density Lipoprotein (c-VLDL) | 0.9 mmol/L | Standard Deviation 0.5 |
| Placebo | Very Low Density Lipoprotein (c-VLDL) | 0.9 mmol/L | Standard Deviation 0.4 |
p-value: 0.88Kruskal-Wallis
Secondary
Waist Circumference
Waist circumference was evaluated at week 12 with a flexible tape
Time frame: Week 12
Population: Two of the study groups have one less patient 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 |
|---|---|---|---|
| Propolis | Waist Circumference | 100.7 cm | Standard Deviation 10 |
| Metformin | Waist Circumference | 102.2 cm | Standard Deviation 11.9 |
| Placebo | Waist Circumference | 101.5 cm | Standard Deviation 10.2 |
p-value: 0.903Kruskal-Wallis