NCT06547515Recruiting
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 156 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- 14 Sept 2022
- Primary completion date
- 15 Aug 2026
- Lead sponsor
- CHU de Quebec-Universite Laval
- Diseases
- Obesity
- NCT number
- NCT06547515
What you commit to
- Study type: Observational
- Planned participants: 156
- From 14 Sept 2022 to the primary completion date, 15 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes;
- Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
- Metabolic bone disease other than osteoporosis or type 2 diabetes,
Lab values
- Creatinine clearance \<30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
Other
- Weight \>204 kg (DXA weight limit) or BMI \>60 kg/m2 (upper limit to allow for QCT examination);
- Current or planned pregnancy during follow-up; breast-feeding.
Who the study is looking for
- Men and women aged \>18 years;
- Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
- Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) \>40 UI/L.
- Women taking oral contraceptive pills or hormone replacement therapy
- Patients with type 2 diabetes.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche de l'IUCPQ Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.