The Effect of Momordica Charantia on Glycemic Control and Insulin Resistance in Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- serum fructosamine at end of trial phase in each of the groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Type 2 diabetics with mild degree of hyperglycemia (FBG >126<200 mg/dl)
- •Absence of serious co-morbid conditions
- •Patients agreeing to participate in this trial
排除标准
- •Type 1 diabetics
- •Paediatric age group
- •Patients known to be allergic to Momordica charantia
- •Serious cardio-respiratory illness, previous myocardial infarction, angina pectoris, heart failure, uncontrolled hypertension ≥ stage 2, COPD, asthma, active pulmonary tuberculosis
- •Significant hepatic impairment: ALT >60, Bilirubin >2 mg/dl
- •Significant renal impairment: S/creatinine >1.5 mg/dl, albuminuria > 1+
- •Patients with conditions likely to interfere with the absorption of the trial therapy: malabsorption, chronic diarrhoea, intestinal resection, blind loop syndrome
- •Patients withholding consent
- •Patients, both male and female, desiring pregnancy during the trial phase.
- •Secondary causes of diabetes
- •Patients using drugs influencing glucose metabolism: steroids, hormonal contraception, menopausal HRT , diazoxide, phenytoin, colchicine
研究组 & 干预措施
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.
干预措施: starch powder (Other)
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.
干预措施: Momordica charantia (Drug)
结局指标
主要结局
serum fructosamine at end of trial phase in each of the groups
时间窗: three weeks
次要结局
- 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)
- GLP-1[7-36] in each group at the end of trial phase(three weeks)
- FBG at end of trial phase in each of the groups(three weeks)
- HOMA-IR in each of the two groups at end of trial phase(three weeks)
- Insulin resistance by the hyperinsulinemic, euglycemic clamp in a subset at the end of trial phase(3 weeks)
研究者
Khadija Irfan Khawaja
Assistant Professor of Endocrinology
Services Hospital, Lahore