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This study has been withdrawn prior to enrollment.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

January 15, 2009
June 9, 2012
November 2008
February 2009   (final data collection date for primary outcome measure)
serum fructosamine at end of trial phase in each of the groups [ Time Frame: three weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823953 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Glycemic Response to Momordica Charantia in Type 2 Diabetes
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • 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
  • 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.
    Intervention: Other: 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.

    Intervention: Drug: Momordica charantia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00823953
DMC0107
Yes
Khadija Irfan Khawaja, Services Hospital, Lahore
Services Hospital, Lahore
University of the Punjab
Principal Investigator: Khadija I Khawaja, MBBS,FCPS Services Hospital, Lahore
Services Hospital, Lahore
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP