Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Guadalajara
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Glycosylated Hemoglobin (A1C)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Propolis
Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Intervention: Propolis (Drug)
Metformin
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Intervention: Metformin (Drug)
Placebo
Placebo capsules, two times per day before break-fast and dinner during 12 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Glycosylated Hemoglobin (A1C)
Time Frame: 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
Fasting Serum Glucose
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week(Week 12)
- Waist Circumference(Week 12)
- Body Mass Index(Week 12)
- Percentage of Fat Mass(Week 12)
- Total Cholesterol(Week 12)
- Triglycerides(Week 12)
- High Density Lipoprotein Cholesterol (c-HDL)(Week 12)
- Low Density Lipoproteins Cholesterol (c-LDL)(Week 12)
- Very Low Density Lipoprotein (c-VLDL)(Week 12)
- Creatinine(Week 12)
- Insulin Sensitivity(Week 12)
- First Phase of Insulin Secretion(Week 12)
- AUC Glucose(Week 12)
- Total Insulin Secretion(Week 12)
- Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week(Week 12)
- Body Weight(Week 12)
- AUC Insulin(Week 12)
- Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week(Week 12)
- Uric Acid(Week 12)
- Systolic Blood Pressure(Week 12)
- Diastolic Blood Pressure(Week 12)
Investigators
Manuel González Ortiz
Researcher Professor
University of Guadalajara