NCT00146289已完成2 期
A Randomised, DB, Placebo-controlled, Parallel Group, 16-wk MICARDIS (160mg) Tab, Proof-of-concept, Evaluating Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive, Using the OGTT, With a Clamp Sub-group
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 17
- 主要终点
- The primary endpoint is the change from baseline to the end of study (16 weeks) in the insulin sensitivity index as estimated by the composite index (R04-1184) calculated from a 3-hour oral glucose tolerance test (OGTT).
研究概览
简要总结
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
- •Subjects 18-65 years old.
- •Body Mass Index (BMI) >=
- •Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
- •Waist circumference >= 40 inches (102 cm) in men and >= 35 inches (89 cm) women.
- •HbA1C assessed <= 6.5%.
- •Triglycerides >= 150, and <= 500 mg/dL.
- •Fasting Glucose <= 126 mg/dL.
- •Blood pressure >= 110/64 and <= 140/90 mmHg.
排除标准
- •Currently taking any antihypertensive medications (e.g., thiazide or loop diuretics), diabetic medications, medications known to alter insulin sensitivity (e.g., statins), steroids, glucocorticoids, niacin, nicotinic acid, and anti-psychotic/depressant drugs (e.g., prozocin). Including over the counter (OTC) and herbal products, which are known to affect metabolic function.
- •Diagnosis of any of the following chronic diseases: hypertension, diabetes mellitus, renal insufficiency, congestive heart failure, hepatic insufficiency, biliary obstructive disorders, autoimmune disease, HIV, coronary artery disease, mental illness, and severe anemia.
- •Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
- •Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
- •Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
- •PCI (percutaneous coronary intervention) within the past 3 months.
- •Stroke within the past 6 months.
- •Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
- •Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- •SGPT (ALT) or SGOT (AST) > 2.5 times the upper limit of normal range, or
- •Serum creatinine > 2.3 mg/dL (or > 203 mol/L)
- •Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
- •Have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
- •Are not surgically sterile, or
- •Are nursing, or pregnant, or
- •Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study and do not agree to periodic pregnancy testing during participation in the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch. No exceptions will be made.
- •Hematocrit < 35%.
- •Primary aldosteronism.
- •Hereditary fructose intolerance.
- •History of drug or alcohol dependency within the previous 6 months.
- •Currently participating in a weight loss program.
- •Any investigational drug therapy within one month of randomisation or during the study.
- •Known hypersensitivity to any component of the study drug (telmisartan or placebo).
- •Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.
结局指标
主要结局
The primary endpoint is the change from baseline to the end of study (16 weeks) in the insulin sensitivity index as estimated by the composite index (R04-1184) calculated from a 3-hour oral glucose tolerance test (OGTT).
次要结局
- From baseline: Glucose disposal rates; Insulin sensitivity (IS) index as Rd/I (clamp); IS index (OGTT- min model); Insulin secretion capacity; fasting insulin & gluc.; AUC gluc & insulin; ratio of AUC glucose ÷ by AUC insulin; lipids & inflam. markers.
研究者
研究点 (17)
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