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
N/A
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
This research focuses on understanding the effects of sleeve gastrectomy, a popular weight loss surgery, on bone and muscle health in adults with obesity. It compares changes in bone mineral density and muscle mass over three years among men, premenopausal women, and postmenopausal women who undergo the surgery, against similar individuals who do not have the surgery. The study aims to assess the risks of bone loss and muscle strength reduction that may occur after this procedure, which is important given concerns about fractures and falls following older types of bariatric surgeries. Participants are divided into four groups: men, premenopausal women, postmenopausal women undergoing sleeve gastrectomy, and a non-surgical group of obese individuals. The study observes changes in spine and femur bone density using quantitative computed tomography and dual-energy X-ray absorptiometry, alongside assessments of muscle mass, quality, and strength. Measurements are taken before surgery, then one year and three years after surgery, to track progress and compare results between surgical and non-surgical groups. Throughout the study, participants will undergo scans and tests to measure bone density and muscle condition, including physical performance evaluations that predict risk of falls and fractures. These assessments are planned at baseline, 1 year, and 3 years after surgery. Researchers monitor changes over time to understand the long-term impact of sleeve gastrectomy on bone and muscle health. The total participation time spans three years, with ongoing evaluation of outcomes related to bone mineral density and muscle mass at specific skeletal sites.
CONDITIONS
Brief 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 over 18 years
- Awaiting sleeve gastrectomy for the bariatric group or meeting criteria for sleeve gastrectomy but not undergoing surgery for the non-surgical group
- Menopause defined as no menstrual periods for a year with serum follicular-stimulating hormone over 40 UI/L
- Women taking oral contraceptive pills or hormone replacement therapy
- Patients with type 2 diabetes
You will not qualify if you...
- Type 1 diabetes
- Uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder
- Metabolic bone disease other than osteoporosis or type 2 diabetes
- Creatinine clearance under 30 ml/min
- Use of medications affecting bone metabolism such as glucocorticoids, anti-epileptic drugs, osteoporosis therapy, or thiazolidinediones
- Weight over 204 kg or BMI over 60 kg/m2
- Current or planned pregnancy during follow-up
- Breast-feeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 1 week
Participants undergoing sleeve gastrectomy receive the bariatric surgery and immediate post-operative care.
1 surgery visit and several post-operative visits
Duration - 3 years
Participants are monitored for changes in bone density, muscle mass, and muscle function before surgery and up to 3 years after surgery or observation for the non-surgical group.
Visits before surgery and follow-up visits at 1 year and 3 years
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here