Status:
RECRUITING
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Bariatric Surgery
Bone Health
Eligibility:
All Genders
18-60 years
Brief Summary
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 peop...
Detailed Description
This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30). Outcome measures are assessed befor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03455868
Start Date
March 15 2018
End Date
December 1 2025
Last Update
June 10 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H3H 2R9
2
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G2
3
Centre de recherche de l'IUCPQ
Québec, Quebec, Canada, G1V 4G5