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NCT Number: NCT02397447

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Momordica charantia

Drug

Momordica Charantia: 2000 mg per day for three months

Other names: Bitter gourd, karela, balsam-pear

Placebo

Drug

Placebo: 2000 mg per day for three months

Other names: Calcined magnesia

Primary outcomes

  1. Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days

    Time frame: 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

  2. Insulin Sensitivity (Matsuda Index) After 90 Days

    Time frame: 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)]

Secondary outcomes

  1. Fasting Serum Glucose (FSG) After 90 Days

    Time frame: 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

  2. A1C After 90 Days

    Time frame: 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

  3. Total Cholesterol After 90 Days

    Time frame: 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

  4. Triglycerides After 90 Days

    Time frame: 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

  5. High Density Lipoprotein Cholesterol (HDL-c) After 90 Days

    Time frame: 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

  6. Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days

    Time frame: 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

  7. Very Low Density Lipoprotein After 90 Days

    Time frame: 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

  8. Alanine Aminotransferase (ALT) After 90 Days

    Time frame: 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

  9. Aspartate Aminotransferase (AST) After 90 Days

    Time frame: 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

  10. Creatinine After 90 Days

    Time frame: 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

  11. Systolic Blood Pressure After 90 Days

    Time frame: 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

  12. Diastolic Blood Pressure After 90 Days

    Time frame: 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

  13. Body Weight (BW) After 90 Days

    Time frame: 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.

  14. Body Mass Index (BMI) After 90 Days

    Time frame: 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

  15. Fat Mass After 90 Days

    Time frame: 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)

  16. Waist Circumference (WC) After 90 Days

    Time frame: 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

  17. 2-h Serum Glucose After 90 Days

    Time frame: 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%

  18. AUC-glucose After 90 Days

    Time frame: 90 days

    The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days

  19. AUC-insulin After 90 Days

    Time frame: 90 days

    The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2015
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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