Conditions: Diabetes Mellitus Type 2
Keywords: Momordica Charantia Insulin secretion Insulin sensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days arm 2: Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days

Interventions: intervention 1: Momordica charantia intervention 2: Placebo
Intervention descriptions: intervention 1: Momordica Charantia: 2000 mg per day for three months intervention 2: Placebo: 2000 mg per day for three months

Protocol document: