Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fasting Plasma Glucose
研究概览
简要总结
Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.
详细描述
The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at 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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 25.0-34.99 kg / m
- •Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)
- •Written informed consent.
- •body weight stable over the last 3 months.
- •Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
- •Women who are not contemplated get pregnant within the next 6 months.
排除标准
- •Women pregnant or breastfeeding.
- •Physical or mental disability that makes it impossible to perform the intervention.
- •Diagnosis of hypertension or heart failure.
- •Untreated thyroid disease.
- •Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
- •Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
- •Diagnosis of renal disease or creatinine > 1.5 mg / dl.
- •Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
- •Total Cholesterol ≥ 280 mg/dL.
- •Triglycerides ≥ 300 mg/dL.
- •Known allergy to calcined magnesia or Gymnema sylvestre.
研究组 & 干预措施
Gymnema Sylvestre
Patients with IGT
干预措施: Gymnema Sylvestre (Drug)
Placebo
Patients with IGT
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Plasma Glucose
时间窗: 90 days
After intervention by spectrophotometry
2-hour Post Load Plasma Glucose (2-h PG)
时间窗: 90 days
The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
Glycated Hemoglobin A1c (A1C)
时间窗: 90 days
After intervention by high-performance liquid chromatography
Insulin Sensitivity (Matsuda Index)
时间窗: 90 days
Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\] after intervention.
Total Insulin Secretion (Insulinogenic Index)
时间窗: 90 days
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
First Phase of Insulin Secretion
时间窗: 90 days
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') after intervention.
次要结局
- Systolic Blood Pressure (SBP)(12 weeks)
- Body Weight (BW)(12 weeks)
- High Density Lipoprotein Cholesterol(90 days)
- Low Density Lipoprotein(90 days)
- Area Under the Curve of Glucose(90 days)
- Area Under the Curve of Insulin(90 days)
- Body Mass Index (BMI)(12 weeks)
- Total Cholesterol(90 days)
- Triglycerides(90 days)
- Waist Circumference (WC)(12 weeks)
- Diastolic Blood Pressure (DBP)(12 weeks)
- Very Low Density Lipoprotein(90 days)
- Creatinine(90 days)
研究者
Esperanza Martínez-Abundis
PHD
University of Guadalajara