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

U

University of Guadalajara

Status and phase

Completed
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Metformin
Drug: Propolis
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03416127
PROPOLIS-METFORMIN-DM2

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 3 patient groups, including a placebo group

Propolis
Experimental group
Description:
Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Treatment:
Drug: Propolis
Metformin
Experimental group
Description:
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Treatment:
Drug: Metformin
Placebo
Placebo Comparator group
Description:
Placebo capsules, two times per day before break-fast and dinner during 12 weeks.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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