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

• Status: Completed
• Trial end date: 2019-12-20
• Target enrollment: 0
• Participant gender: All

Summary

Glycemic control is naturally the principal topic of diabetes and complications that can be developed as a consequence of loss of sensitivity to perceive insulin signals by the cell. The glycemic control goals established by the ADA are: glycosylated hemoglobin (A1C) <7.0%, fasting plasma glucose 80-130 mg/dL and casual plasma glycemia <180 mg/dL. The first-line treatment in patients of recent diagnosis is metformin, however, studies have shown that propolis, a resinous balsamic material collected by the Apis mellifera bee, from sprouts, exudates of trees and other parts of the plants, represents a very important and promising natural alternative in medicine, which can be considered as an antidiabetic agent.

The aim of this study is to evaluate the effect of propolis or metformin administration on glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.

The investigators hypothesis is that propolis or metformin administration, modify the glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Metformin; Propolis

Criteria

Inclusion Criteria:

• Patients both sexes

• Age between 30 and 60 years

• Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl; or glycosylated hemoglobin between >6.5%)

• 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

• Body Mass Index ≥34.9 kg/m2

• 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

• Low density lipoprotein (c-LDL) ≥190 mg/dL

• Blood Pressure ≥140/90 mmHg