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Enrolling by Invitation

NCT Number: NCT07711925

MRI Assessment of Body Composition in Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Warmia and Mazury

Olsztyn, Warminsko-mazusrkie, 10-045, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MRI

Diagnostic Test

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.

Primary outcomes

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

    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.

Secondary outcomes

  1. Change in skeletal muscle volume

    Time frame: Baseline, 3 months, and 12 months after bariatric surgery

    Change in skeletal muscle volume assessed by MRI before and after bariatric surgery.

  2. Change in hepatic fat content

    Time frame: Baseline, 3 months, and 12 months after bariatric surgery

    Change in liver fat content assessed by MRI following bariatric surgery.

  3. Change in glycated hemoglobin (HbA1c)

    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.

  4. Change in serum triglyceride concentration

    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.

  5. Change in lipoprotein(a) concentration

    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.

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury in Olsztyn

Other

Registry information

Official study title

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

Acronym: COMPOSE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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