Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion

University of Guadalajara

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Placebo

Drug: Momordica charantia

Study type

Interventional

Funder types

Other

Identifiers

NCT02397447

MCHDM2

Details and patient eligibility

About

The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.

Full description

A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.

An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.

Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.

Enrollment

24 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study
Fasting glucose: <210 mg/dl
A1C: 7-9%
Body mass index: 25-34.9 kg/m2
Body weight without variations above or under 5% in the last three months before entering the study
Women in childbearing years must have a contraceptive method
Letter of consent and release signed by each patient

Exclusion criteria

Pregnant or suspected pregnant women
Woman breastfeeding
Medications known to affect metabolism of glucose and insulin
Personal history of liver or renal disease
Hypertension, thyroid or cardiovascular disease decompensated
Total cholesterol >= 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate <=60ml/min or liver transaminases >=2.5 the upper normal limit