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
402 weeks
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
Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.
CONDITIONS
Official Title
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 60 years
- For bariatric groups: BMI of 35 kg/m2 or higher
- For type 2 diabetes patients: use of oral hypoglycemic agents or insulin, or diagnosis confirmed by two tests (HbA1c ≥6.5%, fasting glucose ≥7.0 mM, or 2-hour glucose post-OGTT ≥11.1 mM)
- For bariatric group without diabetes: HbA1c below 6.5% and fasting glucose below 7.0 mM
- Control group: BMI between 25.0 and 29.9 kg/m2, no diabetes or prediabetes, stable weight for last 3 months
You will not qualify if you...
- Type 1 diabetes
- Diseases affecting bone metabolism such as uncontrolled thyroid disease, malabsorptive or inflammatory disorders, metabolic bone disease
- Medications affecting bone metabolism, including glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones
- BMI over 60 kg/m2
- Inability to perform CT scan due to size
- Pregnancy or planning pregnancy during study, or women of childbearing age not agreeing to contraception
- History of oesophageal, gastric, or digestive surgery
- Previous bariatric surgery
- Cancer with risk of recurrence during study
- Prosthesis interfering with imaging
- Severe chronic illness preventing participation
- For control group: more than 5% weight change in last 3 months, pregnancy or lactation in past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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