MRI Assessment of Body Composition in Bariatric Surgery (COMPOSE)

July 13, 2026 updated by: Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Warminsko-mazusrkie
      • Olsztyn, Warminsko-mazusrkie, Poland, 10-045
        • University of Warmia and Mazury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Adults Undergoing Bariatric Surgery
Diagnostic test: MRI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 and 12 months after bariatric surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, and 12 months after bariatric surgery
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.
Baseline, 3 months, and 12 months after bariatric surgery
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.
Baseline, 3 months, and 12 months after bariatric surgery.
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.
Baseline, 3 months, and 12 months after bariatric surgery.
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.
Baseline, 3 months, and 12 months after bariatric surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury in Olsztyn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

January 22, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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