Glycemic Response to Momordica Charantia in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00823953
• Other study ID #: DMC0107
• Status: Withdrawn
• Phase: Phase 2
• First received: January 15, 2009
• Last updated: June 9, 2012
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2012
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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:
• 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.

Locations

Country	Name	City	State
Pakistan	Services Hospital	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Services Hospital, Lahore	University of the Punjab

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Ahmed I, Adeghate E, Sharma AK, Pallot DJ, Singh J. Effects of Momordica charantia fruit juice on islet morphology in the pancreas of the streptozotocin-diabetic rat. Diabetes Res Clin Pract. 1998 Jun;40(3):145-51. — View Citation

Ahmed I, Lakhani MS, Gillett M, John A, Raza H. Hypotriglyceridemic and hypocholesterolemic effects of anti-diabetic Momordica charantia (karela) fruit extract in streptozotocin-induced diabetic rats. Diabetes Res Clin Pract. 2001 Mar;51(3):155-61. — View Citation

Dans AM, Villarruz MV, Jimeno CA, Javelosa MA, Chua J, Bautista R, Velez GG. The effect of Momordica charantia capsule preparation on glycemic control in type 2 diabetes mellitus needs further studies. J Clin Epidemiol. 2007 Jun;60(6):554-9. Epub 2006 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum fructosamine at end of trial phase in each of the groups		three weeks	No
Secondary	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	Yes
Secondary	GLP-1[7-36] in each group at the end of trial phase		three weeks	No
Secondary	FBG at end of trial phase in each of the groups		three weeks	No
Secondary	HOMA-IR in each of the two groups at end of trial phase		three weeks	No
Secondary	Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase		3 weeks	No

External Links

•   Database File for Momordica charantia