NCT01344811已完成不适用
A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 661
- 试验地点
- 4
- 主要终点
- Weight Change from Baseline to 24 weeks
研究概览
简要总结
A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.
详细描述
- Objectives : To evaluate superiority of U(Ubiquitous)-Healthcare(hereinafter referred to as Smart Care) Service being combined conventional treatment with health care service, in comparison to conventional treatment in obese patients with metabolic syndrome.
- Test and control group
- Test groups : The subject group who is receiving health care services using conventional treatment (hospital visit) and Smart Care Service (Telemonitoring).
- Control group : The subject group who is receiving conventional treatment (hospital visit).
- Target Subject: Obese patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: More than 20 years of age and under 70 years of age.
- •BMI ≥ 25kg/m2
- •Patients with metabolic syndrome (who have more than three of following 5 components of metabolic syndrome) and who are able to receive outpatient treatment.
- •A. Abdominal obesity: Waist circumference≥90cm(Male), 85cm(Female) B. Patients whose blood pressure ≥130/85mmHg(systolic blood pressure over 130 or, diastolic blood pressure over 85) or patients who are taking blood pressure medication.
- •C. Fasting Blood Glucose (FPG)≥ 100mg/dl. D. Patients whose triglyceride ≥150 mg/dl or patients who are taking fibrate. E. High-density lipoprotein cholesterol (HDL) < 40 mg/dl (Male), 50 mg/dl(Female)
- •Patients who are able to understand the purpose of this trial and to read and write.
- •Patients who are able to use U-healthcare Smartphone for this trial.
- •Patients who participate voluntarily and sign the informed consent.
排除标准
- •Type I diabetes mellitus patients and type II diabetes mellitus patients requiring insulin therapy.
- •Patients currently being hospitalized or planning to hospitalize during the study period.
- •Patients were diagnosed with myocardial infarction or stroke within 1 year
- •End Stage Renal Disease patients requiring renal replacement therapy, Serum creatinine level is greater than 1.5 times the upper limit of normal.
- •Females who are pregnant
- •Hepatic failure (severe hepatic dysfunction). Liver Function Test (AST or ALT) is greater than 3 times the upper limit of normal.
- •Uncontrolled chronic lung disease.
- •Patients with known gallstone.
- •Patients who have cognitive disorder or psychiatric problems.
- •Patients who are taking anti-obesity medications such as Reductil, Xenical, etc., or patients are planning to receive the medications.
- •Patients who are taking Synthroid, diabetes medications or psychiatric medications which may affect on body weight.
- •Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
- •Patients who have participated in other clinical trial (except for the observational study) within 12 weeks prior to screening visit.
结局指标
主要结局
Weight Change from Baseline to 24 weeks
时间窗: 0 and 24 weeks
次要结局
- Changes in lifestyle(0 and 24 weeks)
- Proportion of subjects whose body weight decreased more than 10%(0 and 24 weeks)
- Changes in body fat rate(0 and 24 weeks)
- Changes in the number of metabolic syndrome components(0 and 24 weeks)
- Body Mass Index (BMI) changes(0 and 24 weeks)
- Changes in waist circumference(0 and 24 weeks)
- Changes in blood pressure(0 and 24 weeks)
- Changes in prevalence rate of metabolic syndrome(0 and 24 weeks)
- Patients' satisfaction(24 weeks)
- Changes in lipid profile(0 and 24 weeks)
研究者
Chang Hee, Lee
Chief Research Engineer
LG Electronics Inc.
研究点 (4)
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