Impact of Bariatric Surgery on Bone Health in Type 2 Diabetes Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre de recherche de l'IUCPQ
  Québec, Quebec, Canada Recruiting
• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of Sleeve Gastrectomy on Bone and Muscle Health in Men and Women

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.