Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Change in Total Body Weight
研究概览
简要总结
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
详细描述
All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
干预措施: Phentermine-Topiramate (Drug)
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
干预措施: Liraglutide (Drug)
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
干预措施: Naltrexone/bupropion (Drug)
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
干预措施: Phentermine-Topiramate (Drug)
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
干预措施: Liraglutide (Drug)
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
干预措施: Naltrexone/bupropion (Drug)
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
干预措施: Phentermine (Drug)
结局指标
主要结局
Change in Total Body Weight
时间窗: baseline to 12 weeks
Percent change in body weight
次要结局
- Percentage of Responders(baseline to 12 weeks)
研究者
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic