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Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women

Recruitingn/aAges 18 Years - anyAllCHU de Quebec-Universite Laval
NCT06547515 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fol

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📋 Eligibility rules (as published)
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.
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What it tests

  • Bariatric surgery
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Where

1 site
Centre de recherche de l'IUCPQ
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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