Impact of Bariatric Surgery on Bone Health in Type 2 Diabetes Patients
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
This study is testing how sleeve gastrectomy surgery affects bone health in people with type 2 diabetes compared to those who are overweight but don’t have diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT03455868 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates how sleeve gastrectomy, a common bariatric procedure, affects bone health in patients with type 2 diabetes. It includes a bariatric group undergoing surgery and a control group of overweight individuals without diabetes. Participants will be assessed at multiple time points post-surgery to measure changes in volumetric bone mineral density (vBMD) and identify factors influencing these changes. The study aims to provide insights into the relationship between bariatric surgery and bone health in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with obesity and type 2 diabetes awaiting sleeve gastrectomy.
Not a fit: Patients with type 1 diabetes or those with conditions affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bone health in patients with type 2 diabetes undergoing bariatric surgery.
How similar studies have performed: While the impact of bariatric surgery on metabolic health is well-studied, the specific focus on bone health in this context is less explored, making this study relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * bariatric groups: men and women; 18 to 60 years old; with a BMI \>=35 kg/m2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: HbA1c \>=6.5%; fasting glucose \>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \>=11.1 mM) (guidelines.diabetes.ca);) or without diabetes: HbA1c \<6.5% AND fasting glucose \<7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg/m2 (overweight group); without diabetes or prediabetes: HbA1c \<6.0% AND fasting glucose \<6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months. Exclusion Criteria: * bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \<60 ml/min) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI\>60 kg/m2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project. Control group: Same criteria plus: \>5% change in weight in the last 3 months; pregnancy or lactation in the last year.
Where this trial is running
Montreal, Quebec and 2 other locations
- The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada (Terminated)
- Centre de recherche du CHU de Québec - Université Laval — Québec, Quebec, Canada (Active_not_recruiting)
- Centre de recherche de l'IUCPQ — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Claudia Gagnon, Dr — CHU de Québec - Université Laval
- Study coordinator: Sarah Chouinard-Castonguay
- Email: Sarah.Chouinard-Castonguay@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.