Trials / Recruiting
RecruitingNCT06547515
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 156 (estimated)
- Sponsor
- CHU de Quebec-Universite Laval · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bariatric surgery | Sleeve gastrectomy |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2026-08-15
- Completion
- 2026-08-15
- First posted
- 2024-08-09
- Last updated
- 2025-06-10
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06547515. Inclusion in this directory is not an endorsement.