Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
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
- High Density Lipoprotein-cholesterol (HDL-C) 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 the disease.
Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
详细描述
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.
12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
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 to the IDF criteria
- •Waist circumference
- •Man ≥90 cm
- •Woman ≥80 cm
- •And two of the following criteria:
- •High density lipoprotein
- •Man ≤40 mg/dL
- •Woman ≤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
- •Hypersensibility to resveratrol
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid diseased
- •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
- •Low density lipoprotein (c-LDL) ≥190 mg/dL
- •Blood Pressure ≥140/90 mmHg
研究组 & 干预措施
Banaba
Banaba capsules, 500mg, two times per day before meals during 90 days
干预措施: Banaba (Drug)
Placebo
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
干预措施: placebo (Drug)
结局指标
主要结局
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
时间窗: Week 12
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
First Phase of Insulin Secretion at Week 12
时间窗: Week 12
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 frst phase of insulin secretion at week 12.
Total Insulin Sensitivity at Week 12
时间窗: Week 12
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 at week 12.
Triglyceride Levels at Week 12
时间窗: Week 12
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
Systolic Blood Pressure at Week 12.
时间窗: Week 12
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Total Insulin Secretion at Week 12.
时间窗: Week 12
Measure Description: 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 (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Fasting Glucose Levels at Week 12
时间窗: Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Diastolic Blood Pressure at Week 12
时间窗: Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Waist Circumference at Week 12
时间窗: Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
次要结局
- Body Mass Index at Week 12(Week 12)
- Weight at Week 12(Week 12)
- Total Cholesterol at Week 12(Week 12)
- Low-density Lipoprotein-cholesterol (LDL-C) at Week 12(Week 12)
研究者
Manuel González Ortiz
PHD
University of Guadalajara