DIETary Strategies to stabiLize Incretin-based Weight Loss in Obesity Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 292
- 主要终点
- weight in kg
研究概览
简要总结
So far, treatment with semaglutide (Wegovy) for therapy of obesity demonstrates substantial effects. However, most patients do not desire life-long pharmaceutical therapy or discontinue this treatment regime. This is accompanied by rapid weight regain. Moreover, numerous patients are open to an intermittent therapy.
This trial aims to investigate whether two diet interventions can keep weight stable after weight loss with semaglutide in people with obesity or overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 kg/m² OR ≥ 27 kg/m² with concomitant cardiometabolic risk factors (metabolic syndrome, elevated blood pressure, dyslipidemia or impaired glucose metabolism (but not type 2 diabetes)
排除标准
- •BMI ≥ 45 kg/m²
- •intake of glucose lowering drugs
- •presence of incretin-based treatment
- •acute severe CVD
- •uncontrolled hypertension
- •severe hepatic or renal diseases
- •severe food allergy or malabsorption disease
- •active cancer
- •condition after bariatric surgery
- •history of eating disorder
- •concurrent pregnancy and breastfeeding
研究组 & 干预措施
NutriAct plus
Adults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will follow NutriAct plus for 12 months
干预措施: NutriAct plus (Behavioral)
Rescue VLCD
Adults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will receive rescue VLCD in case of weight regain for 12 months
干预措施: Rescue VLCD (Behavioral)
结局指标
主要结局
weight in kg
时间窗: body weight in kg after weight loss (3 to 5 months) and after dietary intervention (12 months)
weight in kg
时间窗: body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)
次要结局
未报告次要终点
研究者
Knut Mai
Prof. Dr.
Charite University, Berlin, Germany