Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Launched by CHU DE QUEBEC-UNIVERSITE LAVAL · Mar 5, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how bariatric surgery, specifically sleeve gastrectomy (SG), affects bone health in people with type 2 diabetes. Researchers want to understand if this popular weight-loss surgery can improve or worsen bone strength, which can be a concern for individuals with diabetes. They will also look at other factors that might influence bone health after the surgery and compare the results with people who are overweight but do not have diabetes and those who are healthy and not overweight.

To participate in this study, you need to be between 18 and 60 years old and have a body mass index (BMI) of 35 or higher along with type 2 diabetes. Alternatively, if you don’t have diabetes, you should have a BMI between 25 and 29.9 and meet certain health criteria. If you join, you can expect to undergo some tests to assess your bone health before and after the surgery. This trial is important because it aims to provide insights into how bariatric surgery may affect not just weight, but also bone health in people with diabetes, helping to guide future treatments and care.

Gender

ALL

Eligibility 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.