Status:
RECRUITING
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Bariatric Surgery
Bone Health
Eligibility:
All Genders
18+ years
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 div...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06547515
Start Date
September 14 2022
End Date
August 15 2026
Last Update
June 10 2025
Active Locations (1)
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1
Centre de recherche de l'IUCPQ
Québec, Canada, G1V 4G5