Glycemic Response to Momordica Charantia in Type 2 Diabetes

Status Withdrawn

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.

Clinical Trial 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 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

Clinical Trial Details

NCT number	NCT00823953
Study type	Interventional
Source	Services Hospital, Lahore
Contact
Status	Withdrawn
Phase	Phase 2
Start date	November 2008
Completion date	February 2009

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