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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Momordica charantia
Placebo
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Momordica Charantia, Insulin secretion, Insulin sensitivity

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Momordica charantia

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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)]

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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)
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
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%
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
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

Full Information

First Posted
March 10, 2015
Last Updated
September 29, 2020
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT02397447
Brief Title
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Official Title
Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Momordica Charantia, Insulin secretion, Insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Momordica charantia
Arm Type
Experimental
Arm Description
Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days
Intervention Type
Drug
Intervention Name(s)
Momordica charantia
Other Intervention Name(s)
Bitter gourd, karela, balsam-pear
Intervention Description
Momordica Charantia: 2000 mg per day for three months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined magnesia
Intervention Description
Placebo: 2000 mg per day for three months
Primary Outcome Measure Information:
Title
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
Description
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
Time Frame
90 days
Title
Insulin Sensitivity (Matsuda Index) After 90 Days
Description
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)]
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Fasting Serum Glucose (FSG) After 90 Days
Description
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
Time Frame
90 days
Title
A1C After 90 Days
Description
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
Time Frame
90 days
Title
Total Cholesterol After 90 Days
Description
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
Time Frame
90 days
Title
Triglycerides After 90 Days
Description
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
Time Frame
90 days
Title
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
Description
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
Time Frame
90 days
Title
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
Description
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
Time Frame
90 days
Title
Very Low Density Lipoprotein After 90 Days
Description
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
Time Frame
90 days
Title
Alanine Aminotransferase (ALT) After 90 Days
Description
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
Time Frame
90 days
Title
Aspartate Aminotransferase (AST) After 90 Days
Description
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
Time Frame
90 days
Title
Creatinine After 90 Days
Description
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
Time Frame
90 days
Title
Systolic Blood Pressure After 90 Days
Description
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
Time Frame
90 days
Title
Diastolic Blood Pressure After 90 Days
Description
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
Time Frame
90 days
Title
Body Weight (BW) After 90 Days
Description
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.
Time Frame
90 days
Title
Body Mass Index (BMI) After 90 Days
Description
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
Time Frame
90 days
Title
Fat Mass After 90 Days
Description
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)
Time Frame
90 days
Title
Waist Circumference (WC) After 90 Days
Description
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
Time Frame
90 days
Title
2-h Serum Glucose After 90 Days
Description
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%
Time Frame
90 days
Title
AUC-glucose After 90 Days
Description
The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days
Time Frame
90 days
Title
AUC-insulin After 90 Days
Description
The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez Abundis, PhD Science
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

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

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