NCT04622982已完成不适用
Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study
Azienda di Servizi alla Persona di Pavia0 个研究点目标入组 151 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 主要终点
- Body Weight
研究概览
简要总结
This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18
- •BMI >= 30
- •one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)
排除标准
- •active cancer
- •severe cognitive or functional impairments
- •severe behavioral disorders
- •known kidney failure (previous glomerular filtration rate <30 ml/min)
- •known liver failure (Child B or C)
研究组 & 干预措施
All participants
Experimental
Obese subjects with BMI >= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others).
干预措施: Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy) (Other)
结局指标
主要结局
Body Weight
时间窗: 12 weeks
Change in body Weight
次要结局
- GlycaemIa(12 weeks)
- Total cholesterol(12 weeks)
- HDL cholesterol(12 weeks)
- ALT (alanine aminotransferase)(12 weeks)
- Total bilirubin(12 weeks)
- Basal metabolic rate(12 weeks)
- Insulin(12 weeks)
- Homa IR(12 weeks)
- LDL cholesterol(12 weeks)
- Triglycerides(12 weeks)
- AST (Aspartate Aminotransferase)(12 weeks)
- GGT (gamma-glutamyl transpeptidase)(12 weeks)
研究者
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