Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2 | Obesity, Morbid | Bariatric Surgery | Bone HealthBackground: 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 60
Participation 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.
Study Location
The Research Institute of the McGill University Health Centre
The Research Institute of the McGill University Health CentreMontréal, Quebec
Canada
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Centre de recherche de l'IUCPQ
Centre de recherche de l'IUCPQQuébec, Quebec
Canada
Contact Study Team
The Research Institute of the McGill University Health Centre
The Research Institute of the McGill University Health CentreMontreal, Quebec
Canada
Contact Study Team
Centre de recherche du CHU de Québec - Université Laval
Centre de recherche du CHU de Québec - Université LavalQuébec, Quebec
Canada
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- Study Sponsored By
- CHU de Quebec-Universite Laval
- Participants Required
- More Information
- Study ID:
NCT03455868