NCT02706067已完成4 期
Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Percent Change from Baseline in Body Weight at Year 2
研究概览
简要总结
This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss
- •Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat
排除标准
- •Pregnant or lactating females
- •History or presence of significant medical disorders
- •Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes
- •Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis
- •Clinically significant abnormal clinical chemistry or hematology results
- •Excessive alcohol intake
- •Smoking cessation within the previous 6 months
- •History or presence of cancer
- •Administration of medicines known to alter body weight
- •History or presence of cancer
研究组 & 干预措施
Orlistat
Experimental
Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
干预措施: Orlistat (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight at Year 2
时间窗: Baseline and Year 2
Percent Change from Baseline in Body Weight at Year 4
时间窗: Baseline and Year 4
次要结局
- Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria(Every 6 months during Year 1, annually during Years 2 to 4)
- Eating Disorder Inventory (EDI) 2 Subscale and Total Score(Baseline and Year 4)
- Hospital Anxiety and Depression (HAD) Subscale Score(Baseline and Year 4)
- Number of Orlistat Capsules Taken During the Study(Given up to three times per day for 4 years)
- Duration of Orlistat Treatment During the Study(Given up to three times per day for 4 years)
- Waist-to-Hip Circumference Ratio(Baseline and Year 4)
- Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)(Baseline and Year 4)
- Skinfold Thickness (Expressed in Millimeters)(Baseline and Year 4)
- Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)(Baseline and Year 4)
- Number of Kilocalories Expended, Total and at Rest(Baseline and Year 4)
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