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

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

Sponsors

Lead sponsor: University of Guadalajara

Source University of Guadalajara
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.

Overall Status Completed
Start Date March 2013
Completion Date November 2015
Primary Completion Date November 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Total and First Phase of Insulin Secretion (Insulinogenic index and Stumvoll index) 90 days
Insulin Sensitivity (Matsuda index) 90 days
Secondary Outcome
Measure Time Frame
Fasting plasma glucose (spectrophotometry) 90 days
A1C 90 days
Total cholesterol 90 days
Triglycerides 90 days
High density lipoprotein cholesterol 90 days
Low density lipoprotein 90 days
Very low density lipoprotein 90 days
Alanine aminotransferase 90 days
Aspartate aminotransferase 90 days
Creatinine 90 days
Blood pressure 90 days
Enrollment 24
Condition
Intervention

Intervention type: Drug

Intervention name: Momordica charantia

Description: Momordica Charantia: 2000 mg per day for three months

Arm group label: Momordica charantia

Other name: Bitter gourd, karela, balsam-pear

Intervention type: Drug

Intervention name: Placebo

Description: Placebo: 2000 mg per day for three months

Arm group label: Placebo

Other name: 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

Gender: All

Minimum age: 35 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Esperanza Martínez Abundis, PhD Science Principal Investigator Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Location
facility Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Location Countries

Mexico

Verification Date

January 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Guadalajara

Investigator full name: Esperanza Martínez-Abundis

Investigator title: PhD. Esperanza Martínez-Abundis

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Momordica charantia

Arm group type: Experimental

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

Arm group label: Placebo

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov