Clinical trial NCT00823953: Glycemic Response to Momordica Charantia in Type 2 Diabetes
Official title: The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: diabetes type 2
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
Collaborators: name: University of the Punjab
First posted: 2009-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: serum fructosamine at end of trial phase in each of the groups
timeFrame: three weeks
Secondary outcomes:
measure: Development of major adverse effects (e.g. intractable vomiting, jaundice, allergic reactions or other effects requiring cessation of therapy and breaking of study code)
timeFrame: three weeks
measure: GLP-1[7-36] in each group at the end of trial phase
timeFrame: three weeks
measure: FBG at end of trial phase in each of the groups
timeFrame: three weeks
measure: HOMA-IR in each of the two groups at end of trial phase
timeFrame: three weeks
measure: Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Khadija I Khawaja, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0168-8227(98)00022-9.
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. doi: 10.1016/s0168-8227(00)00224-2.
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. doi: 10.1016/j.jclinepi.2006.07.009. Epub 2006 Nov 13.