Trial Outcomes & Findings for Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus (NCT NCT03416127)
NCT ID: NCT03416127
Last Updated: 2022-11-07
Results Overview
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
COMPLETED
PHASE2
36 participants
Week 12
2022-11-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=12 Participants
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.
|
Placebo
n=12 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 7 • n=5 Participants
|
51 years
STANDARD_DEVIATION 4 • n=7 Participants
|
50 years
STANDARD_DEVIATION 5 • n=5 Participants
|
49 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Fasting serum glucose
|
7.3 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
8.0 mmol/L
STANDARD_DEVIATION 1.6 • n=7 Participants
|
7.7 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.7 mmol/L
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
2 hours after OGTT
|
14.6 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
15.8 mmol/L
STANDARD_DEVIATION 2.8 • n=7 Participants
|
13.2 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.5 mmol/L
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Glycosylated Hemoglobin (A1C)
|
6.6 percentage
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.8 percentage
STANDARD_DEVIATION 0.9 • n=7 Participants
|
6.8 percentage
STANDARD_DEVIATION 0.9 • n=5 Participants
|
6.7 percentage
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Total insulin secretion
|
0.5 index
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.4 index
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.5 index
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.5 index
STANDARD_DEVIATION 0.1 • n=4 Participants
|
|
Insulin sensitivity
|
1.0 index
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.1 index
STANDARD_DEVIATION 0.3 • n=7 Participants
|
0.8 index
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.0 index
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
First phase of insulin secretion
|
2092 index
STANDARD_DEVIATION 653 • n=5 Participants
|
1608 index
STANDARD_DEVIATION 736 • n=7 Participants
|
2221 index
STANDARD_DEVIATION 566 • n=5 Participants
|
1984 index
STANDARD_DEVIATION 686 • n=4 Participants
|
|
AUC glucose
|
965 mmol*min/L
STANDARD_DEVIATION 137 • n=5 Participants
|
1039 mmol*min/L
STANDARD_DEVIATION 174 • n=7 Participants
|
930 mmol*min/L
STANDARD_DEVIATION 90 • n=5 Participants
|
978 mmol*min/L
STANDARD_DEVIATION 133.6 • n=4 Participants
|
|
AUC insulin
|
52541 pmol*min/L
STANDARD_DEVIATION 9165 • n=5 Participants
|
45323 pmol*min/L
STANDARD_DEVIATION 9005 • n=7 Participants
|
53869 pmol*min/L
STANDARD_DEVIATION 5053 • n=5 Participants
|
50577.6 pmol*min/L
STANDARD_DEVIATION 7741 • n=4 Participants
|
|
Glucose 30 min after oral glucose tolerance test
|
12.4 mmol/L
STANDARD_DEVIATION 2.3 • n=5 Participants
|
13.7 mmol/L
STANDARD_DEVIATION 3.8 • n=7 Participants
|
12.0 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
12.7 mmol/L
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Glucose 60 min after oral glucose tolerance test
|
15.2 mmol/L
STANDARD_DEVIATION 3.0 • n=5 Participants
|
17.2 mmol/L
STANDARD_DEVIATION 2.9 • n=7 Participants
|
14.7 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
15.6 mmol/L
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Glucose 90 min after oral glucose tolerance test
|
14.7 mmol/L
STANDARD_DEVIATION 2.0 • n=5 Participants
|
17.5 mmol/L
STANDARD_DEVIATION 2.4 • n=7 Participants
|
14.3 mmol/L
STANDARD_DEVIATION 2.8 • n=5 Participants
|
15.5 mmol/L
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Waist circumference
|
101.2 cm
STANDARD_DEVIATION 9.6 • n=5 Participants
|
103.4 cm
STANDARD_DEVIATION 11.7 • n=7 Participants
|
103.2 cm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
102.6 cm
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Body weight
|
76.4 kg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
80.7 kg
STANDARD_DEVIATION 14.4 • n=7 Participants
|
78.6 kg
STANDARD_DEVIATION 13.1 • n=5 Participants
|
78.6 kg
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Body mass index
|
29.0 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 3.13 • n=5 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 3.7 • n=4 Participants
|
|
Percentage of fat mass
|
32.8 % fat mass
STANDARD_DEVIATION 9.7 • n=5 Participants
|
30.7 % fat mass
STANDARD_DEVIATION 6.8 • n=7 Participants
|
33.8 % fat mass
STANDARD_DEVIATION 8.3 • n=5 Participants
|
32.4 % fat mass
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Total cholesterol
|
5.0 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.7 mmol/L
STANDARD_DEVIATION 1.1 • n=7 Participants
|
4.7 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.8 mmol/L
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Triglycerides
|
2.2 mmol/L
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.7 mmol/L
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 1.0 • n=5 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
High Density Lipoprotein cholesterol (c-HDL)
|
1.0 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.9 mmol/L
STANDARD_DEVIATION 0.3 • n=7 Participants
|
0.9 mmol/L
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.9 mmol/L
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Low-Density Lipoproteins-cholesterol (c-LDL)
|
3.0 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.0 mmol/L
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.9 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.0 mmol/L
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Very low density lipoprotein (VLDL)
|
1.0 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
0.8 mmol/L
STANDARD_DEVIATION 0.3 • n=7 Participants
|
0.9 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
0.9 mmol/L
STANDARD_DEVIATION 0.4 • n=4 Participants
|
|
Creatinine
|
72.5 mmol/L
STANDARD_DEVIATION 31.8 • n=5 Participants
|
65.4 mmol/L
STANDARD_DEVIATION 21.2 • n=7 Participants
|
69.8 mmol/L
STANDARD_DEVIATION 27.4 • n=5 Participants
|
70.7 mmol/L
STANDARD_DEVIATION 26.5 • n=4 Participants
|
|
Uric acid
|
356.9 mmol/L
STANDARD_DEVIATION 71.4 • n=5 Participants
|
315.2 mmol/L
STANDARD_DEVIATION 65.4 • n=7 Participants
|
309.2 mmol/L
STANDARD_DEVIATION 89.2 • n=5 Participants
|
327.1 mmol/L
STANDARD_DEVIATION 77.3 • n=4 Participants
|
|
Systolic blood pressure
|
116.9 mmHg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
118.4 mmHg
STANDARD_DEVIATION 10.6 • n=7 Participants
|
115.7 mmHg
STANDARD_DEVIATION 7.2 • n=5 Participants
|
117.0 mmHg
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Diastolic blood pressure
|
76.5 mmHg
STANDARD_DEVIATION 7.8 • n=5 Participants
|
76.2 mmHg
STANDARD_DEVIATION 7.0 • n=7 Participants
|
73.4 mmHg
STANDARD_DEVIATION 6.7 • n=5 Participants
|
75.4 mmHg
STANDARD_DEVIATION 7.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Fasting Serum Glucose
|
6.6 mmol/L
Standard Deviation 0.9
|
7.3 mmol/L
Standard Deviation 1.1
|
8.2 mmol/L
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
2 Hours After Oral Glucose Tolerance Test in Week 12
|
13.1 mmol/L
Standard Deviation 1.9
|
13.7 mmol/L
Standard Deviation 2.7
|
13.2 mmol/L
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Week 12Population: 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
Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Glycosylated Hemoglobin (A1C)
|
6.3 % of A1C
Standard Deviation 0.9
|
6.6 % of A1C
Standard Deviation 0.8
|
7.0 % of A1C
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Total Insulin Secretion
|
0.5 index
Standard Deviation 0.2
|
0.3 index
Standard Deviation 0.2
|
0.5 index
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Insulin Sensitivity
|
1.5 index
Standard Deviation 0.6
|
1.8 index
Standard Deviation 1.0
|
1.0 index
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
First Phase of Insulin Secretion
|
1346 index
Standard Deviation 784
|
996 index
Standard Deviation 742
|
1652 index
Standard Deviation 863
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
AUC Glucose
|
921 mmol*min/L
Standard Deviation 126
|
967 mmol*min/L
Standard Deviation 116
|
939 mmol*min/L
Standard Deviation 126.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
AUC Insulin
|
44123 pmol*min/L
Standard Deviation 13381
|
27603 pmol*min/L
Standard Deviation 15935
|
51287 pmol*min/L
Standard Deviation 7440
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week
|
12.3 mmol/L
Standard Deviation 2.0
|
12.5 mmol/L
Standard Deviation 2.1
|
12.0 mmol/L
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week
|
15.1 mmol/L
Standard Deviation 2.8
|
15.9 mmol/L
Standard Deviation 2.5
|
14.2 mmol/L
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week
|
14.2 mmol/L
Standard Deviation 2.6
|
16.6 mmol/L
Standard Deviation 2.1
|
14.9 mmol/L
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Waist circumference was evaluated at week 12 with a flexible tape
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Waist Circumference
|
100.7 cm
Standard Deviation 10.0
|
102.2 cm
Standard Deviation 11.9
|
101.5 cm
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Body Weight
|
75.3 kg
Standard Deviation 11.3
|
81.0 kg
Standard Deviation 15.2
|
77.8 kg
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Body Mass Index
|
28.6 kg/m2
Standard Deviation 4.3
|
29.2 kg/m2
Standard Deviation 3.8
|
30.0 kg/m2
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Percentage of fat mass was evaluated through bioimpedance.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Percentage of Fat Mass
|
32.8 % of fat mass
Standard Deviation 10.3
|
28.4 % of fat mass
Standard Deviation 6.8
|
33.6 % of fat mass
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Total Cholesterol
|
5.1 mmol/L
Standard Deviation 0.7
|
4.6 mmol/L
Standard Deviation 0.9
|
4.7 mmol/L
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Triglycerides
|
2.0 mmol/L
Standard Deviation 0.8
|
2.0 mmol/L
Standard Deviation 1.0
|
1.9 mmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 12Population: 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
c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
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 0.1
|
SECONDARY outcome
Timeframe: Week 12Population: 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
c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Low Density Lipoproteins Cholesterol (c-LDL)
|
3.1 mmol/L
Standard Deviation 0.5
|
2.7 mmol/L
Standard Deviation 0.5
|
3.0 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Very Low Density Lipoprotein (c-VLDL)
|
0.9 mmol/L
Standard Deviation 0.4
|
0.9 mmol/L
Standard Deviation 0.5
|
0.9 mmol/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Creatinine
|
55.7 mmol/L
Standard Deviation 10.6
|
74.2 mmol/L
Standard Deviation 16.8
|
63.6 mmol/L
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: Week 12Population: 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
Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Uric Acid
|
339.0 mmol/L
Standard Deviation 77.3
|
327.1 mmol/L
Standard Deviation 71.4
|
333.1 mmol/L
Standard Deviation 95.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Systolic Blood Pressure
|
114.6 mmHg
Standard Deviation 7.4
|
119.2 mmHg
Standard Deviation 11.4
|
112.8 mmHg
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
Propolis
n=12 Participants
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.
|
Metformin
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|---|
|
Diastolic Blood Pressure
|
74.8 mmHg
Standard Deviation 7.4
|
74.4 mmHg
Standard Deviation 7.9
|
72.3 mmHg
Standard Deviation 3.8
|
Adverse Events
Propolis
Metformin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Propolis
n=12 participants at risk
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.
|
Metformin
n=12 participants at risk
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.
|
Placebo
n=12 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
8.3%
1/12 • Number of events 1 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
16.7%
2/12 • Number of events 2 • Throughout the study, an average of 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
8.3%
1/12 • Number of events 1 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
16.7%
2/12 • Number of events 2 • Throughout the study, an average of 12 weeks
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Throughout the study, an average of 12 weeks
|
8.3%
1/12 • Number of events 1 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
0.00%
0/12 • Throughout the study, an average of 12 weeks
|
8.3%
1/12 • Number of events 1 • Throughout the study, an average of 12 weeks
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place