跳至主要内容
临床试验/NCT03482986
NCT03482986进行中(未招募)不适用

Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
2
主要终点
Post-intervention change in self-rated hunger

研究概览

简要总结

The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

详细描述

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
22 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Bariatric surgery (sleeve gastrectomy) patients

排除标准

  • Insulin-dependent diabetes
  • Shift work within the past 1 year
  • Drug or alcohol dependency
  • Bipolar disorder
  • Post traumatic stress disorder (PTSD)

结局指标

主要结局

Post-intervention change in self-rated hunger

时间窗: Baseline and 4 weeks (post-intervention)

Differences in self-rated hunger as measured from the visual analogue scale (VAS; 0-100 score with 0 as ''not at all'' and 100 as ''very much''/''extremely'') questionnaire at baseline and after the intervention

次要结局

  • Change in caloric intake(baseline and 4 weeks (post-intervention))
  • Change in glucose tolerance(baseline and 4 weeks (post-intervention))
  • Change in energy expenditure(baseline and 4 weeks (post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank AJL Scheer, PhD

Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

Loading locations...

相似试验