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

NCT ID: NCT02397447

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Momordica charantia

Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days

Group Type: EXPERIMENTAL

Momordica charantia

Intervention Type: DRUG

Momordica Charantia: 2000 mg per day for three months

Placebo

Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo: 2000 mg per day for three months

Interventions

Momordica charantia

Momordica Charantia: 2000 mg per day for three months

Intervention Type: DRUG

Placebo

Placebo: 2000 mg per day for three months

Intervention Type: DRUG

Other Intervention Names

Bitter gourd, karela, balsam-pear; Calcined magnesia

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Esperanza Martínez-Abundis

PhD. Esperanza Martínez-Abundis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esperanza Martínez Abundis, PhD Science

Role: PRINCIPAL_INVESTIGATOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Locations

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

MCHDM2

Identifier Type: -

Identifier Source: org_study_id