AzTrials
AzTrials

Obesity (BMI>30)COMPOSENCT07711925

MRI Assessment of Body Composition in Bariatric Surgery

A study testing MRI in people with Obesity (BMI>30), run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity (BMI>30)
What is being tested?
MRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePoland
Study dates
22 Jan 2026to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

  • University of Warmia and Mazury

    Olsztyn, Warminsko-mazusrkie, 10-045

Other trials in Poland

About this study

Official title: 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?

Read more

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.

Read the 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.

Being tested
MRI
Keywords
obesory, bmi, body composition, sleeve gastrectomy, bariatric surgery, MRI
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDiagnostic 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.

Study groups in NCT07711925
Study groupRoleWhat they receive
Adults Undergoing Bariatric SurgeryOtherNot described
Receives: Diagnostic Test: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline and 3 and 12 months after bariatric surgery

Secondary outcomes (5)

  1. Change in skeletal muscle volume

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

    Measured: Baseline, 3 months, and 12 months after bariatric surgery

  2. Change in hepatic fat content

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

    Measured: Baseline, 3 months, and 12 months after bariatric surgery

  3. Change in glycated hemoglobin (HbA1c)

    Change in glycated hemoglobin (HbA1c) [%] concentration following bariatric surgery and its association with MRI-derived body composition changes.

    Measured: Baseline, 3 months, and 12 months after bariatric surgery.

  4. Change in serum triglyceride concentration

    Change in fasting serum triglyceride [mg/dL] concentration following bariatric surgery and its association with MRI-derived body composition changes.

    Measured: Baseline, 3 months, and 12 months after bariatric surgery.

  5. Change in lipoprotein(a) concentration

    Change in serum lipoprotein(a) [nmol/L] concentration following bariatric surgery and its association with MRI-derived body composition changes.

    Measured: Baseline, 3 months, and 12 months after bariatric surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start22 Jan 2026
  3. Primary completion22 Jan 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective longitudinal cohort study in which adults undergoing bariatric surgery will be followed for 12 months. Participants will undergo serial magnetic resonance imaging (MRI) examinations before surgery and during postoperative follow-up to evaluate changes in adipose tissue distribution and skeletal muscle composition and their association with metabolic outcomes.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711925
Sponsor's protocol ID
53/2025
Acronym
COMPOSE
Status last verified
Jan 2026
First submitted
13 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bai J, Wang S, Pan H, Shi Z, Zhao M, Yue X, Yang K, Zhang X, Wang W, Liu C, Zhang T. Correlation analysis of dynamic changes of abdominal fat during rapid weight loss after bariatric surgery: A prospective magnetic resonance imaging study. Eur J Radiol. 2024 Sep;178:111630. doi: 10.1016/j.ejrad.2024.111630. Epub 2024 Jul 15.

    PubMed 39024662

  • Shang-Guan ZX, Lin GT, Liu ZY, Zhong Q, Huang Q, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Zheng HL, Zheng CH, Lin JX, Huang CM. Effect of Sarcopenic Obesity on Weight Loss Outcomes and Quality of Life after Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study. Obes Surg. 2024 May;34(5):1479-1490. doi: 10.1007/s11695-024-07146-z. Epub 2024 Mar 15.

    PubMed 38489003

  • Emamat H, Jamshidi A, Farhadi A, Ghalandari H, Ghasemi M, Tangestani H. The association between the visceral to subcutaneous abdominal fat ratio and the risk of cardiovascular diseases: a systematic review. BMC Public Health. 2024 Jul 9;24(1):1827. doi: 10.1186/s12889-024-19358-0.

    PubMed 38982435

  • Neeland IJ, Ross R, Despres JP, Matsuzawa Y, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin B, Zambon A, Barter P, Fruchart JC, Eckel RH; International Atherosclerosis Society; International Chair on Cardiometabolic Risk Working Group on Visceral Obesity. Visceral and ectopic fat, atherosclerosis, and cardiometabolic disease: a position statement. Lancet Diabetes Endocrinol. 2019 Sep;7(9):715-725. doi: 10.1016/S2213-8587(19)30084-1. Epub 2019 Jul 10.

    PubMed 31301983

Questions about this trial

What is this clinical trial studying?

A study testing MRI in people with Obesity (BMI>30), run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in abdominal adipose tissue distribution assessed by magnetic resonance imaging (MRI) (time frame: Baseline and 3 and 12 months after bariatric surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07711925, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in