Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Fasting Glucose Levels at Week 12
研究概览
简要总结
The metabolic syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers from the disease and predispose the onset of diseases like cardiovascular disease and diabetes mellitus type 2.
The first line of treatment for metabolic syndrome is diet and exercise but patients have a low attachment to the treatment, so pharmacologic therapy is required. There is no a single drug that could help to the treatment of all metabolic syndrome components.
Irvingia gabonensis, better known as African mango, is widely consumed in central and western Africa, mainly the fruit and seeds. Besides being part of the diet of African the seeds have been used for the treatment of diseases such as dysentery, diabetes and as an analgesic.
Resent investigations have demonstrated that an extract of African mango seeds induce significantly weight loss in subjects with obesity, and also improves some biochemical parameters such as glucose and the lipid profile.
The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic syndrome, insulin secretion and insulin sensitivity.
详细描述
A randomized, double-blind, placebo-controlled, clinical trial is going to be carried out in 24 patients of both sexes aged between 30 and 60 years, with diagnosis of metabolic syndrome according to the modified International Diabetes Federation (IDF) criteria (without diabetes and without previous treatment for metabolic syndrome components).
The patients will be assigned randomly into two groups of 12 patients each. The patients will receive 150 mg of Irvingia gabonensis before breakfast and dinner (300 mg per day) or placebo during 12 weeks.
Waist circumference, triglycerides, high density lipoproteins (HDL-c) and blood pressure will be evaluated before and after intervention in both groups.
First phase of insulin secretion (Stumvoll index), total insulin secretion (Insulinogenic index) and Insulin sensitivity (Matsuda index) will be calculated from the concentration of glucose and insulin obtained from an Oral Glucose Tolerance Test.
Data from statistical analysis will be presented through measures of central tendency and dispersion, mean and standard deviation for quantitative variables and frequencies and percentages for qualitative variables. Qualitative variables will be analyzed by X2. The inter group differences will be analyzed through Mann-Whitney U test and Wilcoxon Test for intra-group differences. Statistical significance will be considered with a p<0.05.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 30 and 60 years
- •Metabolic syndrome according IDF modified criteria
- •Waist circumference: Men ≥90 cm, women ≥80 cm
- •And two of the following criteria:
- •HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL
- •Fasting glucose ≥100 mg/dL
- •Triglycerides ≥150 mg/dL
- •Blood pressure ≥130/85 mmHg
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Known hypersensibility to Irvingia gabonensis
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid disease
- •Previous treatment for the metabolic syndrome components
- •Body mass index ≥ 39.9 kg/m2
- •Fasting glucose ≥126 mg/dL
- •Triglycerides ≥ 500 mg/dL
- •Total cholesterol ≥ 240 mg/dL
- •LDL-C ≥190 mg/dL
- •Blood pressure ≥140/90 mmHg
结局指标
主要结局
Fasting Glucose Levels at Week 12
时间窗: 12 weeks
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Triglycerides Levels at Week 12
时间窗: 12 weeks
Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
High Density Lipoprotein (HDL-C) Levels at Week 12
时间窗: 12 weeks
The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Total Insulin Secretion at Week 12
时间窗: 12 weeks
Total insulin secretion will be calculated at baseline and week 12 with the insulinogenic index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Systolic Blood Pressure at Week 12
时间窗: 12 weeks
The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Diastolic Blood Pressure at Week 12.
时间窗: Baseline. Week 12
The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Total Insulin Sensitivity at Week 12
时间窗: 12 weeks
Insulin sensitivity will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity
Waist Circumference at Week 12
时间窗: 12 weeks
The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape
First Phase of Insulin Secretion at Week 12
时间窗: 12 weeks
The first phase of insulin secretion will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
次要结局
- Total Cholesterol at Week 12(12 weeks)
- Body Mass Index at Week 12(12 weeks)
- Low Density Lipoproteins (LDL-C) at Week 12(12 weeks)
- Aspartate Aminotransferase at Week 12(12 weeks)
- Alanine Aminotransferase at Week 12(12 weeks)
- Creatinine at Week 12(12 weeks)
- Body Weight at Week 12(12 weeks)
- Uric Acid at Week 12(12 weeks)
研究者
Manuel González Ortiz
Researcher Professor
University of Guadalajara