Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
- Conditions
- Severe ObesityMuscle HealthBariatric SurgeryBone Health
- Interventions
- Procedure: Bariatric surgery
- Registration Number
- NCT06547515
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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.
- Type 1 diabetes;
- Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
- Metabolic bone disease other than osteoporosis or type 2 diabetes,
- Creatinine clearance <30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sleeve gastrectomy - Men Bariatric surgery n = 39 men with obesity undergoing sleeve gastrectomy Sleeve gastrectomy - Premenopausal women Bariatric surgery n = 39 premenopausal women with obesity undergoing sleeve gastrectomy Sleeve gastrectomy - Postmenopausal women Bariatric surgery n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy
- Primary Outcome Measures
Name Time Method Change in vBMD at the spine (L2-L3) and proximal femur before, 1 year after and 3 years after bariatric surgery assessed by QCT
Change in muscle mass at mid-femur before, 1 year after and 3 years after bariatric surgery determined by measuring cross-sectional area at mid-femur (CT)
- Secondary Outcome Measures
Name Time Method Change in aBMD at skeletal sites before, 1 year after and 3 years after bariatric surgery assessed by DXA
Change in muscle quality at mid-femur before, 1 year after and 3 years after bariatric surgery muscle fat infiltration, using CT attenuation in Hounsfield unit (HU)
Change in vBMD at skeletal sites other than the spine before, 1 year after and 3 years after bariatric surgery assessed by QCT
Change in muscle strength before, 1 year after and 3 years after bariatric surgery assessed by CT
Change in lower extremity muscle strength before, 1 year after and 3 years after bariatric surgery knee extensor strength
Change in whole body muscle mass before, 1 year after and 3 years after bariatric surgery assessed by DXA
Change in upper extremity muscle strength before, 1 year after and 3 years after bariatric surgery by hand grip strength
Change in muscle mass (muscle cross-sectional area) and function before, 1 year after and 3 years after bariatric surgery by 6-minute walk test
Trial Locations
- Locations (1)
Centre de recherche de l'IUCPQ
🇨🇦Québec, Canada