NCT07711925

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jan 2026May 2027

Study Start

First participant enrolled

January 22, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 17, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 13, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

obesorybmibody compositionsleeve gastrectomybariatric surgeryMRI

Outcome Measures

Primary Outcomes (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.

    Baseline and 3 and 12 months after bariatric surgery

Secondary Outcomes (5)

  • 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.

Study Arms (1)

Adults Undergoing Bariatric Surgery

OTHER
Diagnostic Test: MRI

Interventions

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.

Adults Undergoing Bariatric Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Warmia and Mazury

Olsztyn, Warminsko-mazusrkie, 10-045, Poland

Location

Related Publications (4)

  • 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.

    PMID: 39024662BACKGROUND
  • 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.

    PMID: 38489003BACKGROUND
  • 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.

    PMID: 38982435BACKGROUND
  • 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.

    PMID: 31301983BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of UWM, MD, PhD

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start

January 22, 2026

Primary Completion (Estimated)

January 22, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations