Effect of Three Lifestyle Interventions on Endothelial Function, Anthropometric Parameters and Cardiometabolic Profile in Obese Patients With Metabolic Syndrome: a Randomized Controlled Trial .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- endothelial mediated vasodilation
研究概览
简要总结
Obese patients with metabolic syndrome without diabetes or ischemic heart disease were randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style diet adapted to brazilian habits with portion control plus fitness three times a week under direct supervision. The main outcome was brachial reactivity, a surrogate marker of atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat proportion and insulin sensitivity.
详细描述
It's a 12 week single center randomized controlled trial to evaluate three different lifestyle interventions on flow mediated vasodilatation, cardiometabolic profile and anthropometric parameters in non-diabetic persons with metabolic syndrome without coronary heart disease.
After informed consent, they will be randomized to 3 different lifestyle interventions: 1. Hypocaloric tailored AHA type 1 diet plus standard exercise advice; 2. Pragmatic portion controlled healthy diet plus pedometers to perform 10.000 steps daily or 3. pragmatic portion controlled healthy diet plus fitness under direct supervision,using heart rate monitors to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate - HRpeak, as determined by their individual maximal treadmill exercise test).Main outcome is endothelium vasodilation accessed through brachial ultrasound, a surrogate marker of atherosclerosis. Secondary outcomes are anthropometric data: weight, waist circumference and fat proportion, cardiometabolic profile and insulin sensitivity (HOMA-R).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women 30-55 years with BMI 30-40 and waist 95 cm or more
- •normal OGTT
- •normal treadmill stress test
- •plus 2 of 4:
- •low serum levels of HDL cholesterol (<40 mg⁄dL for men or < 50 mg ⁄dL for women);
- •hypertriglyceridemia (triglyceride levels of 150 mg⁄dL or greater);
- •impaired glucose homeostasis (fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT or
- •hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs).
排除标准
- •ischemic heart disease or any abnormality on treadmill stress test
- •inflammatory or chronic disorder
- •pregnancy
- •lactation
- •creatinine level of 1,5 mg/dL or more
- •gastrointestinal problems or musculoskeletal disorders that would prevent them to follow the test diets or exercise interventions
- •liver dysfunction with a factor of at least 3 above the upper limit of normal in AST and ALT levels
- •thyroid dysfunction, with serum TSH out of normal limits
- •use of immunosuppressive drugs, corticosteroids or anorexigen
结局指标
主要结局
endothelial mediated vasodilation
时间窗: at enrollment, after 6 and after 12 weeks
次要结局
- weight(randomization, 6 and 12 weeks)