Glycemic Response to Momordica Charantia in Type 2 Diabetes

Phase 2

Withdrawn

• Conditions: Type 2 Diabetes
• Interventions: Other: starch powder; Drug: Momordica charantia

• Registration Number: NCT00823953
• Lead Sponsor: Services Hospital, Lahore

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-09
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult Type 2 diabetics with mild degree of hyperglycemia (FBG >126<200 mg/dl)
2. Absence of serious co-morbid conditions
3. Patients agreeing to participate in this trial

Exclusion Criteria

1. Type 1 diabetics
2. Pregnancy
3. Paediatric age group
4. Patients known to be allergic to Momordica charantia
5. Serious cardio-respiratory illness, previous myocardial infarction, angina pectoris, heart failure, uncontrolled hypertension ≥ stage 2, COPD, asthma, active pulmonary tuberculosis
6. Significant hepatic impairment: ALT >60, Bilirubin >2 mg/dl
7. Significant renal impairment: S/creatinine >1.5 mg/dl, albuminuria > 1+
8. Patients with conditions likely to interfere with the absorption of the trial therapy: malabsorption, chronic diarrhoea, intestinal resection, blind loop syndrome
9. Patients withholding consent
10. Patients, both male and female, desiring pregnancy during the trial phase.
11. Secondary causes of diabetes
12. Patients using drugs influencing glucose metabolism: steroids, hormonal contraception, menopausal HRT , diazoxide, phenytoin, colchicine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	starch powder	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.
Momordica charantia	Momordica charantia	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.

Primary Outcome Measures

Name	Time	Method
serum fructosamine at end of trial phase in each of the groups	three weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Services Hospital; 🇵🇰 Lahore, Punjab, Pakistan