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临床试验/NCT07711925
NCT07711925Enrolling By Invitation不适用

Assessment of Adipose Tissue and Skeletal Muscle Distribution by Magnetic Resonance Imaging in Patients Before and After Surgical Treatment of Obesity

University of Warmia and Mazury in Olsztyn1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Change in abdominal adipose tissue distribution assessed by magnetic resonance imaging (MRI)

研究概览

简要总结

The goal of this observational study is to evaluate changes in adipose tissue and skeletal muscle distribution using magnetic resonance imaging (MRI) in adults with obesity undergoing bariatric surgery. The study also aims to investigate the relationship between MRI-derived body composition parameters and metabolic outcomes following surgical treatment of obesity. The main questions it aims to answer are:

How does bariatric surgery affect the distribution of visceral, subcutaneous, hepatic, perirenal adipose tissue and skeletal muscle over 12 months? Are changes in MRI-derived body composition associated with improvements in metabolic parameters after bariatric surgery?

Participants will:

undergo MRI examinations before bariatric surgery and at 1, 6, and 12 months after surgery; undergo routine clinical and metabolic assessments during standard postoperative follow-up; have MRI-derived body composition measurements correlated with metabolic outcomes over the 12-month follow-up period.

详细描述

Obesity is a chronic metabolic disease associated with increased morbidity and mortality. Beyond body mass index (BMI), the distribution of adipose tissue, particularly visceral adipose tissue, plays a critical role in the development of insulin resistance, type 2 diabetes, cardiovascular disease, and metabolic dysfunction-associated steatotic liver disease. In addition, skeletal muscle quantity and quality are increasingly recognized as important determinants of metabolic health and postoperative recovery.

Magnetic resonance imaging (MRI) is considered the reference standard for non-invasive assessment of body composition, allowing accurate quantification of visceral and subcutaneous adipose tissue, skeletal muscle volume, intramuscular fat infiltration, and ectopic fat depots without exposure to ionizing radiation. Although bariatric surgery has been shown to induce substantial weight loss and improve metabolic outcomes, the temporal changes in regional adipose tissue distribution and skeletal muscle composition remain incompletely understood.

This prospective observational study aims to characterize longitudinal changes in body composition using MRI in patients undergoing bariatric surgery. MRI examinations will be performed before surgery and during postoperative follow-up to evaluate changes in visceral, subcutaneous, hepatic, perirenal, and intramuscular fat, as well as skeletal muscle volume. These imaging findings will be correlated with routinely collected clinical and metabolic parameters to improve understanding of body composition remodeling after bariatric surgery.

The results of this study may contribute to identifying imaging biomarkers associated with metabolic improvement after bariatric surgery and support the development of more personalized strategies for postoperative monitoring and patient management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Age 18 years or older
  • BMI >= 30 kg/m2
  • qualified to undergo bariatric surgery
  • Ability to provide written informed consent
  • Willingness to undergo magnetic resonance imaging before surgery and 3, and 12 months after surgery

排除标准

  • Previous bariatric surgery
  • Presence of ferromagnetic implants or other contraindications to magnetic resonance imaging
  • Previous plastic or surgical procedures affecting the body region assessed by MRI, except cholecystectomy, appendectomy, or inguinal hernia repair
  • Chronic kidney disease stage 4 or higher
  • Pregnancy
  • Claustrophobia preventing MRI examination
  • Inability or unwillingness to provide informed consent

结局指标

主要结局

Change in abdominal adipose tissue distribution assessed by magnetic resonance imaging (MRI)

时间窗: Baseline and 3 and 12 months after bariatric surgery

Change in visceral and subcutaneous abdominal adipose tissue volume measured by MRI and its association with metabolic outcomes following bariatric surgery.

次要结局

  • Change in skeletal muscle volume(Baseline, 3 months, and 12 months after bariatric surgery)
  • Change in hepatic fat content(Baseline, 3 months, and 12 months after bariatric surgery)
  • Change in glycated hemoglobin (HbA1c)(Baseline, 3 months, and 12 months after bariatric surgery.)
  • Change in serum triglyceride concentration(Baseline, 3 months, and 12 months after bariatric surgery.)
  • Change in lipoprotein(a) concentration(Baseline, 3 months, and 12 months after bariatric surgery.)

研究者

发起方
University of Warmia and Mazury in Olsztyn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalia Dowgiałło-Gornowicz, MD, PhD

Prof. of UWM, MD, PhD

University of Warmia and Mazury in Olsztyn

研究点 (1)

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