University of Warmia and Mazury
Olsztyn, Warminsko-mazusrkie, 10-045, Poland
NCT Number: NCT07711925
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Olsztyn, Warminsko-mazusrkie, 10-045, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnetic resonance imaging (MRI) will be used to assess body composition before bariatric surgery and at 1, 3, and 12 months after surgery. MRI examinations will quantify visceral and subcutaneous adipose tissue, skeletal muscle volume, intramuscular fat, hepatic fat, and perirenal fat. Imaging findings will be analyzed longitudinally and correlated with routine clinical and metabolic parameters to evaluate changes in body composition following bariatric surgery.
Time frame: 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.
Time frame: Baseline, 3 months, and 12 months after bariatric surgery
Change in skeletal muscle volume assessed by MRI before and after bariatric surgery.
Time frame: Baseline, 3 months, and 12 months after bariatric surgery
Change in liver fat content assessed by MRI following bariatric surgery.
Time frame: Baseline, 3 months, and 12 months after bariatric surgery.
Change in glycated hemoglobin (HbA1c) [%] concentration following bariatric surgery and its association with MRI-derived body composition changes.
Time frame: Baseline, 3 months, and 12 months after bariatric surgery.
Change in fasting serum triglyceride [mg/dL] concentration following bariatric surgery and its association with MRI-derived body composition changes.
Time frame: Baseline, 3 months, and 12 months after bariatric surgery.
Change in serum lipoprotein(a) [nmol/L] concentration following bariatric surgery and its association with MRI-derived body composition changes.
University of Warmia and Mazury in Olsztyn
Other
Assessment of Adipose Tissue and Skeletal Muscle Distribution by Magnetic Resonance Imaging in Patients Before and After Surgical Treatment of Obesity
Acronym: COMPOSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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