Impact of Sleeve Gastrectomy on Bone and Muscle Health in Men and Women
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
This study is trying to see how sleeve gastrectomy affects bone and muscle health in men and women over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 1 site (Québec) |
| Trial ID | NCT06547515 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of sleeve gastrectomy (SG) on bone and muscle health in men and women, including premenopausal and postmenopausal women. It will compare changes in spine volumetric bone mineral density (vBMD) and muscle mass at the mid-femur between individuals who undergo SG and those who do not. Participants will be followed for three years, with assessments conducted using quantitative computed tomography (QCT) and computed tomography (CT). The study seeks to understand the potential risks associated with SG, particularly regarding bone and muscle loss.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years old who are either awaiting sleeve gastrectomy or meet the criteria for surgery but are not undergoing the procedure.
Not a fit: Patients with type 1 diabetes, uncontrolled thyroid disease, or other metabolic bone diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term effects of sleeve gastrectomy on bone and muscle health, potentially guiding better post-operative care for patients.
How similar studies have performed: While there is existing research on the effects of bariatric surgery on bone health, this specific focus on sleeve gastrectomy and its comparative analysis with non-surgical peers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Québec
- Centre de recherche de l'IUCPQ — Québec, Canada (Recruiting)
Study contacts
- Principal investigator: Claudia Gagnon, Dr — CHU de Québec - Université Laval
- Study coordinator: Sandrine Hegg-Deloye, PhD
- Email: sandrine.hegg-deloye@crchudequebec.ulaval.ca
- Phone: 4185254444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.