Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
研究概览
简要总结
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
详细描述
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.
An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.
Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study
- •Fasting glucose: <210 mg/dl
- •A1C: 7-9%
- •Body mass index: 25-34.9 kg/m2
- •Body weight without variations above or under 5% in the last three months before entering the study
- •Women in childbearing years must have a contraceptive method
- •Letter of consent and release signed by each patient
排除标准
- •Pregnant or suspected pregnant women
- •Woman breastfeeding
- •Medications known to affect metabolism of glucose and insulin
- •Personal history of liver or renal disease
- •Hypertension, thyroid or cardiovascular disease decompensated
- •Total cholesterol >= 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate <=60ml/min or liver transaminases >=2.5 the upper normal limit
研究组 & 干预措施
Placebo
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days
干预措施: Placebo (Drug)
Momordica charantia
Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days
干预措施: Momordica charantia (Drug)
结局指标
主要结局
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
时间窗: 90 days
Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively
Insulin Sensitivity (Matsuda Index) After 90 Days
时间窗: 90 days
Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]
次要结局
- Fasting Serum Glucose (FSG) After 90 Days(90 days)
- Aspartate Aminotransferase (AST) After 90 Days(90 days)
- Creatinine After 90 Days(90 days)
- Systolic Blood Pressure After 90 Days(90 days)
- 2-h Serum Glucose After 90 Days(90 days)
- A1C After 90 Days(90 days)
- Total Cholesterol After 90 Days(90 days)
- Triglycerides After 90 Days(90 days)
- High Density Lipoprotein Cholesterol (HDL-c) After 90 Days(90 days)
- Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days(90 days)
- Very Low Density Lipoprotein After 90 Days(90 days)
- Alanine Aminotransferase (ALT) After 90 Days(90 days)
- Body Mass Index (BMI) After 90 Days(90 days)
- Diastolic Blood Pressure After 90 Days(90 days)
- Fat Mass After 90 Days(90 days)
- Waist Circumference (WC) After 90 Days(90 days)
- Body Weight (BW) After 90 Days(90 days)
- AUC-glucose After 90 Days(90 days)
- AUC-insulin After 90 Days(90 days)
研究者
Esperanza Martínez-Abundis
PhD. Esperanza Martínez-Abundis
University of Guadalajara