Phase 2
N=36
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03416127 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Fasting Serum Glucose — 6.6; 7.3; 8.2 mmol/L — p=0.031
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propolis (Drug); Metformin (Drug); Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Serum Glucose |
6.6; 7.3; 8.2 | 0.031 sig |
| PRIMARY 2 Hours After Oral Glucose Tolerance Test in Week 12 |
13.1; 13.7; 13.2 | 0.963 |
| PRIMARY Glycosylated Hemoglobin (A1C) |
6.3; 6.6; 7.0 | 0.236 |
| SECONDARY Total Insulin Secretion |
0.5; 0.3; 0.5 | 0.015 sig |
| SECONDARY Insulin Sensitivity |
1.5; 1.8; 1.0 | 0.017 sig |
| SECONDARY First Phase of Insulin Secretion |
1346; 996; 1652 | 0.162 |
| SECONDARY AUC Glucose |
921; 967; 939 | 0.686 |
| SECONDARY AUC Insulin |
44123; 27603; 51287 | 0.004 sig |
| SECONDARY Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week |
12.3; 12.5; 12.0 | 0.945 |
| SECONDARY Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week |
15.1; 15.9; 14.2 | 0.332 |
| SECONDARY Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week |
14.2; 16.6; 14.9 | 0.075 |
| SECONDARY Waist Circumference |
100.7; 102.2; 101.5 | 0.903 |
| SECONDARY Body Weight |
75.3; 81.0; 77.8 | 0.697 |
| SECONDARY Body Mass Index |
28.6; 29.2; 30.0 | 0.668 |
| SECONDARY Percentage of Fat Mass |
32.8; 28.4; 33.6 | 0.308 |
| SECONDARY Total Cholesterol |
5.1; 4.6; 4.7 | 0.318 |
| SECONDARY Triglycerides |
2.0; 2.0; 1.9 | 0.880 |
| SECONDARY High Density Lipoprotein Cholesterol (c-HDL) |
1.0; 0.9; 0.9 | 0.376 |
| SECONDARY Low Density Lipoproteins Cholesterol (c-LDL) |
3.1; 2.7; 3.0 | 0.210 |
| SECONDARY Very Low Density Lipoprotein (c-VLDL) |
0.9; 0.9; 0.9 | 0.880 |
| SECONDARY Creatinine |
55.7; 74.2; 63.6 | 0.059 |
| SECONDARY Uric Acid |
339.0; 327.1; 333.1 | 0.978 |
| SECONDARY Systolic Blood Pressure |
114.6; 119.2; 112.8 | 0.122 |
| SECONDARY Diastolic Blood Pressure |
74.8; 74.4; 72.3 | 0.551 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03416127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.