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Glycemic Response to Momordica Charantia in Type 2 Diabetes

This study has been withdrawn prior to enrollment.
(IP could not be made available in sufficient quantity for the expected enrollment)
Sponsor:
Collaborator:
University of the Punjab
Information provided by (Responsible Party):
Khadija Irfan Khawaja, Services Hospital, Lahore
ClinicalTrials.gov Identifier:
NCT00823953
First received: January 15, 2009
Last updated: June 9, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Momordica charantia
Other: starch powder
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Services Hospital, Lahore:

Primary Outcome Measures:
  • serum fructosamine at end of trial phase in each of the groups [ Time Frame: three weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • GLP-1[7-36] in each group at the end of trial phase [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • FBG at end of trial phase in each of the groups [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • HOMA-IR in each of the two groups at end of trial phase [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: starch powder
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 Name: Bitter Melon Capsule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823953

Locations
Pakistan
Services Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
University of the Punjab
Investigators
Principal Investigator: Khadija I Khawaja, MBBS,FCPS Services Hospital, Lahore
  More Information

Additional Information:
Database File for Momordica charantia  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Khadija Irfan Khawaja, Assistant Professor of Endocrinology, Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT00823953     History of Changes
Other Study ID Numbers: DMC0107
Study First Received: January 15, 2009
Last Updated: June 9, 2012
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Services Hospital, Lahore:
diabetes type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013