Effect of Gymnema Sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Waist Circumference (WC)
研究概览
简要总结
Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.
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 modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.
Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.
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
- Triple (Participant, Care Provider, 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
- •Letter of consent and release signed by each patient
- •Body mass index: 25-34.99 kg/m2
- •Body weight without variations above or under 5% during the three months prior to the study
- •Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)
- •Plus any two of the following four factors:
- •Triglycerides: 150-499 mg/dL.
- •High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL.
- •Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
- •Fasting glucose: 100-125 mg/dL
排除标准
- •Type 1 or 2 diabetes mellitus
- •Previous pharmacological treatment for components of metabolic syndrome
- •Mental or physical illness interfering with the study
- •Thyroid or cardiovascular disease
- •Pregnant or suspected pregnant women
- •Woman breastfeeding
- •Index of body mass: ≥ 35 kg/m2
- •Treatments known to affect metabolism of glucose, fats and affecting arterial tension
- •Patients with hepatic or renal diseases background
- •Patients diagnosed with kidneys disease
- •Calcined magnesium intolerance
- •Gymnema Sylvestre intolerance
研究组 & 干预措施
Placebo
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
干预措施: Placebo (Drug)
Gymnema Sylvestre
600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
干预措施: Gymnema Sylvestre (Drug)
结局指标
主要结局
Waist Circumference (WC)
时间窗: Week 12
The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Triglycerides (TGs)
时间窗: week 12
The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
High-density Lipoprotein Cholesterol (HDL-C)
时间窗: Week 12
The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.
Fasting Plasma Glucose (FPG)
时间窗: week 12
The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
Systolic Blood Pressure (SBP)
时间窗: week 12
The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
Diastolic Blood Pressure (DBP)
时间窗: week 12
The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
Total Insulin Secretion
时间窗: Week 12
The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).
First Phase of Insulin Secretion
时间窗: week 12
The 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').
Insulin Sensitivity
时间窗: week 12
The insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\].
次要结局
- Body Weight (BW)(week 12)
- Body Mass Index (BMI)(week 12)
- Total Cholesterol (TC)(week 12)
- 2-hour Postload Plasma Glucose (2-h PG)(week 12)
- Area Under the Curve of Insulin (AUCI)(week 12)
- Very-low Density Lipoprotein (VLDL)(week 12)
- Low-density Lipoprotein Cholesterol (LDL-C)(Week 12)
- Area Under the Curve of Glucose (AUCG)(week 12)
研究者
Esperanza Martínez-Abundis
Researcher Professor
University of Guadalajara