Glycemic Response to Momordica Charantia in Type 2 Diabetes

Study Overview
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Brief Summary
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Diabetes is a common disease which has been treated by traditional medicines for centuries before modern medicine became available. A very common remedy for Diabetes Mellitus in different cultures is momordica charantia (karela or Bitter gourd). The use of alternative medicine is common among Pakistani population. This study was planned to find out the effect of administering freeze dried powder of momordica charantia for three weeks on the glycemic profile and insulin resistance of treatment naiive patients with mild Type 2 diabetes.

Detailed Description
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Momordica charantia is a commonly consumed vegetable, which has formed a part of subcontinental diet since centuries. It has been traditionally used to treat diabetes across three continents, and its glycemic effect has been investigated in a few unblinded trials, but so far no properly designed double blind investigation of its action on insulin resistance has not been carried out. In this study, a randomised placebo controlled double-blind trial will be carried out on mild type 2 diabetic patients, to study the effect of escalating doses of Momordica charantia administered in the form of capsules for the trial phase of three weeks, on glycemic control and parameters of insulin resistance in type 2 diabetes. Among the parameters to be tested will be glucose indices and lipid profile and insulin levels. The effect of Momordica charantia administration on insulin resistance will be assessed using HOMA-IR model and/ or the hyperinsulinemic, euglycemic clamp. The selection of patients with mild hyperglycemia will be done to offset the glucose spill-off effect which occurs beyond the real threshold, and makes the glucose tolerance curve non-linear beyond this level.

Official Title
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The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Momordica charantia
* Other: starch powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Type 2 diabetics with mild degree of hyperglycemia (FBG >126<200 mg/dl) Absence of serious co-morbid conditions Patients agreeing to participate in this trial Exclusion Criteria: Type 1 diabetics Pregnancy Paediatric age group Patients known to be allergic to Momordica charantia Serious cardio-respiratory illness, previous myocardial infarction, angina pectoris, heart failure, uncontrolled hypertension ≥ stage 2, COPD, asthma, active pulmonary tuberculosis Significant hepatic impairment: ALT >60, Bilirubin >2 mg/dl Significant renal impairment: S/creatinine >1.5 mg/dl, albuminuria > 1+ Patients with conditions likely to interfere with the absorption of the trial therapy: malabsorption, chronic diarrhoea, intestinal resection, blind loop syndrome Patients withholding consent Patients, both male and female, desiring pregnancy during the trial phase. Secondary causes of diabetes Patients using drugs influencing glucose metabolism: steroids, hormonal contraception, menopausal HRT , diazoxide, phenytoin, colchicine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo powder (wheat flour) The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3. | Other: starch powder<br>* The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3.<br>|
| Active Comparator: Momordica charantia<br>Thirty patients will be assigned to each arm in a double blind manner. The active arm will be administered capsules containing a total of 500 mg of Momordica charantia freeze dried powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3. The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3. | Drug: Momordica charantia<br>* escalating doses of Momordica charantia administered in the form of capsules for the trial phase of three week.Dose level 1: capsules containing a total of 500 mg of freeze dried powder of Momordica charantia. Dose level 1: capsules containing a total of 1000 mg of freeze dried powder of Momordica charantia. Dose level 3: capsules containing a total of 1500mg of freeze dried powder of Momordica charantia.<br>* Other names: Bitter Melon Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum fructosamine at end of trial phase in each of the groups |  | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of major adverse effects (e.g. intractable vomiting, jaundice, allergic reactions or other effects requiring cessation of therapy and breaking of study code) |  | three weeks | 
| GLP-1[7-36] in each group at the end of trial phase |  | three weeks | 
| FBG at end of trial phase in each of the groups |  | three weeks | 
| HOMA-IR in each of the two groups at end of trial phase |  | three weeks | 
| Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes type 2