Actively Recruiting
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Led by CHU de Quebec-Universite Laval · Updated on 2025-06-10
156
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
C
CHU de Quebec-Universite Laval
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged >18 years
- Awaiting sleeve gastrectomy for the bariatric group or meeting criteria for sleeve gastrectomy but not having surgery for the non-surgical group
- Menopause defined as absence of menses for a year and serum follicular-stimulating hormone (FSH) >40 UI/L
- Women using oral contraceptive pills or hormone replacement therapy
- Patients with type 2 diabetes
You will not qualify if you...
- Type 1 diabetes
- Uncontrolled thyroid disease or overt inflammatory disorder
- Metabolic bone disease other than osteoporosis or type 2 diabetes
- Creatinine clearance <30 ml/min
- Use of medications affecting bone metabolism such as glucocorticoids, anti-epileptic drugs, osteoporosis therapy, or thiazolidinediones
- Weight over 204 kg or body mass index over 60 kg/m2
- Current or planned pregnancy during follow-up or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre de recherche de l'IUCPQ
Québec, Canada, G1V 4G5
Actively Recruiting
Research Team
S
Sandrine Hegg-Deloye, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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