Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
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
- Postprandial Glucose Levels at Week 12
研究概览
简要总结
The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide.
Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes.
Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity.
The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.
详细描述
A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24 patients with diagnosis of glucose intolerance in accordance with the criteria of American Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid, and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose will be held.
12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before breakfast and dinner during 3 months. And other 12 patients will receive placebo with the same prescription.
Area Under de Curve of glucose and insulin will be calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.
Results will be presented as mean and standard deviation. Intra an inter group differences will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p<0.05 will be considered significant.
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
- •Glucose intolerance according ADA criteria (blood glucose leve ≥140 mg/dl and ≤199 mg/dL after an oral glucose tolerance test with 75 of oral glucose
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to Artemisia dracunculus
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid disease
- •Previous treatment for glucose
- •Diabetes diagnosis
- •BMI ≥39.9 kg/m2
结局指标
主要结局
Postprandial Glucose Levels at Week 12
时间窗: Week 12
Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Total Insulin Secretion at Week 12
时间窗: Week 12
Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index. 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
Insulin Sensitivity at Week 12
时间窗: Week 12
Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index. 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
Fasting Glucose Levels at Week 12
时间窗: Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Glycosylated Hemoglobin at Week 12
时间窗: Week 12
Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
First Phase of Insulin Secretion at Week 12
时间窗: Week 12
The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index. 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
- Triglycerides Levels at Week 12(Week 12)
- Aspartate Aminotransferase (AST) Levels at Week 12(Week 12)
- Alanine Aminotransferase (ALT) Levels at Week 12(Week 12)
- Body Mass Index at Week 12(Week 12)
- High Density Lipoprotein (c-HDL) Levels at Week 12(Week 12)
- Uric Acid Levels at Week 12(Week 12)
- Systolic Blood Pressure at Week 12(Week 12)
- Weight at Week 12(Week 12)
- Total Cholesterol at Week 12(Week 12)
- Creatinine Levels at Week 12(Week 12)
- Diastolic Blood Pressure at Week 12.(Week 12)
研究者
Manuel González Ortiz
Researcher Professor
University of Guadalajara