Changes in Adipose and Muscle Tissue Function and Their Impact on Metabolic Health Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Skeletal Muscle Fat Infiltration and Quality (measured by MRI)
研究概览
简要总结
This prospective, single-center observational cohort study aims to explore the relationship between skeletal muscle quality, fat distribution, and metabolic health in Chinese patients with obesity, and to evaluate how bariatric surgery influences these parameters.
A total of 120 participants will be enrolled, including 60 patients undergoing bariatric surgery and 60 age- and sex-matched healthy controls. The study involves cross-sectional comparisons of ectopic fat and muscle composition, as well as longitudinal follow-up of surgical patients at multiple time points up to 5 years postoperatively.
MRI will be used to quantify regional fat and muscle composition, while metabolic parameters, inflammatory markers, and gut microbiota profiles will also be assessed. Primary outcomes include skeletal muscle mass and fat infiltration, visceral and subcutaneous fat volumes, and changes in insulin resistance.
This study seeks to clarify the mechanisms by which bariatric surgery improves metabolic function and to identify early changes in muscle-fat composition that may predict long-term metabolic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Skeletal Muscle Fat Infiltration and Quality (measured by MRI)
时间窗: Baseline, 3 months, 12 months, annually up to 5 years
Quantitative evaluation of intramuscular fat content using MRI-derived proton density fat fraction (PDFF) and muscle attenuation indices in the thigh and paraspinal muscles. Muscle quality will be assessed by MRI signal intensity and texture features to detect early changes in muscle composition post-surgery.
Change in Visceral and Subcutaneous Fat Volume (measured by MRI)
时间窗: Baseline, 3 months, 12 months, annually up to 5 years
MRI-based measurement of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), liver fat percentage (LFP), and pancreatic fat percentage (PFP) to track region-specific fat redistribution after bariatric surgery.
次要结局
- Change in fasting glucose(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in HbA1c(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in triglycerides(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in LDL-C(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in HDL-C(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in total cholesterol(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in insulin resistance(Baseline, 3 months, 12 months, annually up to 5 years)
- Change in body mass index(Baseline, 3 months, 12 months annually up to 5 years)
- Change in waist circumference(Baseline, 3 months, 12 months annually up to 5 years)
- Change in hip circumference(Baseline, 3 months, 12 months annually up to 5 years)
研究者
Shaihong Zhu
Chief of Metabolic and Bariatric Surgery, Xiangya Third Hospital, Central South University
The Third Xiangya Hospital of Central South University