Glycemic Response to Momordica Charantia in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

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.

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

starch powder

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Momordica charantia

Intervention Type DRUG

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.

Interventions

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Momordica charantia

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.

Intervention Type DRUG

starch powder

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.

Intervention Type OTHER

Other Intervention Names

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Bitter Melon Capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No