Bone marrow fat changes after gastric bypass versus sleeve in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study enrolling postmenopausal women with obesity who are scheduled for first-time RYGB or SG to measure bone marrow fat fraction (BMFF) before and after surgery. Participants will undergo imaging to quantify BMFF and blood tests to profile glycemic control, lipids, adipokines (leptin, adiponectin), calciotropic hormones, and other candidate mediators such as G-CSF. The primary analytic approach compares BMFF changes between surgical types and by diabetic status, and explores correlations between BMFF change and metabolic/hormonal factors. The goal is to identify patterns and potential biological mediators that might explain bariatric surgery–associated bone loss.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Postmenopausal women (defined as last menses \>12 months)

* Obesity with a BMI ≥ 35 kg/m²,
* Patients with an indication for bariatric surgery with two surgical techniques, RYGB and SG, but who have never had a bariatric surgery procedure previously,
* Patients who have signed the informed consent.

Exclusion Criteria:

* History of an osteoporotic fracture 2- Current corticosteroid therapy or corticosteroid therapy within the past 3 months, C-onditions or treatments affecting bone metabolism (breast cancer treated with aromatase inhibitors, malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism…),
* History of radiation therapy to the lumbar spine or the hip being studied,
* Patients on hormone replacement therapy (HRT) or patients already on anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide, or denosumab) other than calcium and/or vitamin D supplementation,
* Chronic kidney disease with a creatinine clearance (CKD-EPI formula) ≤ 30 mL/min,
* Weight \> 160 kg, as the bone densitometer table is limited to this weight for the examination,
* Patients who have previously undergone bariatric surgery,
* Patients with orthopedic implants in both hips or the lumbar spine,
* Individuals unable to give personal consent,
* Individuals under legal guardianship or conservatorship,
* Patients not enrolled in a social security program.
* Any contraindication to MRI: (claustrophobia, patients with a pacemaker/defibrillator, cochlear implant, neurostimulator, or orthopedic implants in the hip, pelvis, or lumbar spine, etc.).

Where it's running

• Hopital Roger Salengro, CHU Lille
  Lille, France Recruiting

Study contacts

• Principal investigator: Julien PACCOU, MD,PhD — University Hospital, Lille
• Study coordinator: Julien PACCOU, MD,PhD
• Email: julien.paccou@chru-lille.fr
• Phone: 0320445962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.