Actively Recruiting
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Led by CHU de Quebec-Universite Laval · Updated on 2025-06-10
100
Participants Needed
3
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
Researchers are studying the effects of sleeve gastrectomy, a popular weight loss surgery, on bone health in adults with type 2 diabetes. The study aims to see how this surgery impacts volumetric bone mineral density (vBMD) and to compare these effects with those in obese patients without diabetes and overweight individuals without diabetes or obesity. The goal is to understand how diabetes and bariatric surgery together affect bone strength over time. The study is observational and includes two groups: 70 adults with obesity undergoing sleeve gastrectomy, some with type 2 diabetes and some without, and 30 overweight adults without diabetes serving as controls. Participants in the surgery group are evaluated before surgery and again at 4 months, 8 months, 1 year, and 3 years after the procedure. The control group is assessed once. The main treatment studied is the sleeve gastrectomy surgery, and its impact on bone and metabolic health is monitored. Participants will undergo various tests and assessments including quantitative computed tomography (QCT) scans to measure bone density at the spine, hip, tibia, and radius before surgery and during follow-up visits. Blood tests will track bone turnover markers, glucose control, and hormone levels. Body composition, muscle strength, physical activity, nutrition, and gut microbiota will also be measured at multiple timepoints. Researchers will monitor changes over three years to evaluate long-term bone health and related factors in this population.
CONDITIONS
Brief Title
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Men and women with a body mass index (BMI) of 35 or higher
- For diabetes group: diagnosed type 2 diabetes with treatment or confirmed by blood tests
- For non-diabetes group: HbA1c below 6.5% and fasting glucose below 7.0 mM
- Control group: BMI between 25.0 and 29.9, no diabetes or prediabetes, stable weight for last 3 months
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Diseases or medications affecting bone metabolism (e.g., uncontrolled thyroid disease, metabolic bone disease, glucocorticoids, osteoporosis treatments)
- BMI over 60
- Unable to undergo CT scan (e.g., too large for scanner)
- Pregnant, planning pregnancy, or not agreeing to contraception if of childbearing age
- History of esophageal, gastric, digestive, or bariatric surgery
- Cancer with risk of recurrence
- Prosthesis interfering with imaging
- Severe chronic illness preventing participation
- Control group: more than 5% weight change in last 3 months, pregnancy or lactation in last year
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 - Day of surgery and days following as needed
Participants undergo sleeve gastrectomy surgery and receive immediate care following the procedure.
1 surgical visit (in-person)
Duration - Up to 3 years after surgery
Participants have follow-up visits after surgery to assess bone health and other health markers at multiple time points.
Visits at 4 months, 8 months, 1 year, and 3 years after surgery (in-person)
Duration - Single visit
Participants in the control group undergo a single assessment visit for comparison purposes.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H3H 2R9
Terminated
2
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G2
Active, Not Recruiting
3
Centre de recherche de l'IUCPQ
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
S
Sarah Chouinard-Castonguay
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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