Clinical Trials Directory

Trials / Completed

CompletedNCT02397447

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

Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Guadalajara · Academic / Other
Sex
All
Age
35 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGMomordica charantiaMomordica Charantia: 2000 mg per day for three months
DRUGPlaceboPlacebo: 2000 mg per day for three months

Timeline

Start date
2013-03-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2015-03-25
Last updated
2020-10-22
Results posted
2020-10-22

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT02397447. Inclusion in this directory is not an endorsement.