Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Recruiting · NCT06547515 · Observational (researchers observe without assigning treatment) · Lead sponsor: CHU de Quebec-Universite Laval
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Centre de recherche de l'IUCPQ - Québec, Canada