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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Momordica charantia; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Momordica charantia; Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days	Drug: Momordica charantia; Momordica Charantia: 2000 mg per day for three months; Other Names: Bitter gourd, karela, balsam-pear
Placebo Comparator: Placebo; Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days	Drug: Placebo; Placebo: 2000 mg per day for three months; Other Names: Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days	Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively	90 days
Insulin Sensitivity (Matsuda Index) After 90 Days	Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Serum Glucose (FSG) After 90 Days	The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1	90 days
A1C After 90 Days	A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively	90 days
Total Cholesterol After 90 Days	The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Triglycerides After 90 Days	The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days	The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days	The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Very Low Density Lipoprotein After 90 Days	The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5	90 days
Alanine Aminotransferase (ALT) After 90 Days	The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Aspartate Aminotransferase (AST) After 90 Days	The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Creatinine After 90 Days	The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method	90 days
Systolic Blood Pressure After 90 Days	The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg	90 days
Diastolic Blood Pressure After 90 Days	The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg	90 days
Body Weight (BW) After 90 Days	The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.	90 days
Body Mass Index (BMI) After 90 Days	The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres	90 days
Fat Mass After 90 Days	Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)	90 days
Waist Circumference (WC) After 90 Days	The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters	90 days
2-h Serum Glucose After 90 Days	The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1%	90 days
AUC-glucose After 90 Days	The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days	90 days
AUC-insulin After 90 Days	The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days	90 days

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Investigators: Principal Investigator: Esperanza Martínez Abundis, PhD Science, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Insulin sensitivity; Insulin secretion; Momordica Charantia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases; Hyperinsulinism; Hypersensitivity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: MCHDM2