Bone marrow fat changes after gastric bypass versus sleeve in postmenopausal women
Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss
This study will test whether bone marrow fat changes differently after gastric bypass (RYGB) versus sleeve gastrectomy (SG) in postmenopausal women with obesity and whether those changes relate to diabetes status and metabolic or hormonal markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | denosumab, radiation |
| Locations | 1 site (Lille) |
| Trial ID | NCT05005039 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women (last menses >12 months) with BMI ≥35 kg/m² who are scheduled for their first RYGB or SG and who do not have major conditions or treatments affecting bone metabolism.
Not a fit: Patients already on anti-osteoporotic therapy, recent corticosteroid treatment, or with conditions that affect bone metabolism (for example uncontrolled hyperthyroidism, primary hyperparathyroidism, or recent spine/hip radiation) are unlikely to benefit and may be excluded.
Why it matters
Potential benefit: If successful, the findings could help identify mechanisms of bone loss after bariatric surgery and inform strategies to protect bone health in this population.
How similar studies have performed: Prior studies have reported inconsistent results and no single molecular mechanism has been confirmed, so this observational approach is exploratory rather than building on a clearly established success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.