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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397447
• Other study ID #: MCHDM2
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: September 2020
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Insulin Resistance

Intervention

Drug:
• Momordica charantia
Momordica Charantia: 2000 mg per day for three months
• Placebo
Placebo: 2000 mg per day for three months

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?ABC insulin / ?ABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively	90 days
Primary	Insulin Sensitivity (Matsuda Index) After 90 Days	Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / vglucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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