Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT03416127

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2019-12-20

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propolis

Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.

Group Type: EXPERIMENTAL

Propolis

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.

Interventions

Propolis

Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.

Intervention Type: DRUG

Metformin

Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.

Intervention Type: DRUG

Placebo

Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Metformin hydrochloride; Calcined magnesium

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Manuel González Ortiz

Researcher Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MANUEL GONZALEZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Intstituto de Terapeútica Experimental y Clínica.

Locations

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PROPOLIS-METFORMIN-DM2

Identifier Type: -

Identifier Source: org_study_id