Glycemic Response to Momordica Charantia in Type 2 Diabetes

June 9, 2012 updated by: Khadija Irfan Khawaja, Services Hospital, Lahore

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: 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.
Active Comparator: 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.
Drug: 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.
Other Names:
  • Bitter Melon Capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: three weeks
three weeks
GLP-1[7-36] in each group at the end of trial phase
Time Frame: three weeks
three weeks
FBG at end of trial phase in each of the groups
Time Frame: three weeks
three weeks
HOMA-IR in each of the two groups at end of trial phase
Time Frame: three weeks
three weeks
Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Collaborators

University of the Punjab

Investigators

  • Principal Investigator: Khadija I Khawaja, MBBS,FCPS, Services Hospital, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 9, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMC0107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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