Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Mar 2013
Longer than P75 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
October 22, 2020
CompletedOctober 22, 2020
September 1, 2020
2.7 years
March 10, 2015
September 6, 2020
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
Fasting Serum Glucose (FSG) After 90 Days
90 days
A1C After 90 Days
90 days
Total Cholesterol After 90 Days
90 days
Triglycerides After 90 Days
90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
90 days
- +14 more secondary outcomes
Study Arms (2)
Momordica charantia
EXPERIMENTALTwo 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days
Placebo
PLACEBO COMPARATORTwo 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days
Interventions
Momordica Charantia: 2000 mg per day for three months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dra. Esperanza Martínez Abundis
- Organization
- Institute of Experimental and Clinical Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Esperanza Martínez Abundis, PhD Science
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD. Esperanza Martínez-Abundis
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 25, 2015
Study Start
March 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 22, 2020
Results First Posted
October 22, 2020
Record last verified: 2020-09