NCT06547515 Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
| NCT ID | NCT06547515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Bariatric Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 156 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2026-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 156 participants in total. It began in 2022-09-14 with a primary completion date of 2026-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Claudia Gagnon, Dr
PRINCIPAL INVESTIGATOR
CHU de Québec - Université Laval
Frequently Asked Questions
Who can join the NCT06547515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bariatric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06547515 currently recruiting?
Yes, NCT06547515 is actively recruiting participants. Contact the research team at sandrine.hegg-deloye@crchudequebec.ulaval.ca for enrollment information.
Where is the NCT06547515 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT06547515 clinical trial?
NCT06547515 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Claudia Gagnon, Dr at CHU de Québec - Université Laval. The trial plans to enroll 156 participants.