Diabetes Mellitus, Type 2 Clinical Trial
— BODIOfficial title:
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
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 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Research Institute of the McGill University Health Centre | Montréal | Quebec |
Canada | Centre de recherche du CHU de Québec - Université Laval | Quebec | |
Canada | Centre de recherche de l'IUCPQ | Québec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval | McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bone microarchitecture and metabolism | by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry | during surgery | |
Other | Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5) | Using the algorithm-based qualitative method (ABQ) and the Genant method | before, 1 year after and 3 years after bariatric surgery | |
Other | Prevalence and incidence of falls | by questionnaire | before, 1 year after and 3 years after bariatric surgery | |
Other | Prevalence and incidence of non-vertebral fractures | by questionnaire (self-reported) | before, 1 year after and 3 years after bariatric surgery | |
Primary | Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius | assessed by quantitative computed tomography (QCT) | before, 1 year after and 3 years after bariatric surgery | |
Primary | Change in areal bone mineral density at lumbar spine, hip and radius | assessed by dual-energy X-ray absorptiometry (DXA) | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in N-terminal propeptide of type 1 procollagen (P1NP) | serum bone formation marker | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated) | serum bone formation marker | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in bone alkaline phosphatase | serum bone formation marker | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in C-telopeptide | serum bone resorption marker | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in fasting glucose | diabetes control | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in HbA1c | diabetes control | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in fasting insulin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in serum 25-hydroxyvitamin D | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in parathormone (PTH) | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in estradiol and estrone | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in insulin like growth factor (IGF)-1 | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in sclerostin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in adiponectin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in leptin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in peptide YY (PYY) | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in ghrelin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in oxidative stress markers | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in serum advanced glycation end products (AGEs) | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in Free fatty acids (FFA) | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in fat and lean mass | body composition assessed by bioimpedance and by DXA | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in visceral and subcutaneous adipose tissue | body composition assessed by computed tomography (CT) | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in muscle mass and fat content at mid-femur | assessed by computed tomography (CT) | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in upper extremity muscle strength | assessed by hand grip strength | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in lower extremity muscle strength | assessed by knee extensor strength | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in muscle function | assessed by timed up and go test | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in physical capacity | assessed by 6-minute walk test | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in balance | assessed by Fullerton Advanced Balance (FAB) Scale | before and 1 year after bariatric surgery | |
Secondary | Change in sociodemographic factors | questionnaire | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in nutrition | 3 web-based 24-h recalls | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in self-reported physical activity level | by questionnaire | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in measured physical activity level | by accelerometer | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in gut microbiota | stool sample | before, 1 year after and 3 years after bariatric surgery | |
Secondary | Change in cutaneous Advanced glycation end products (AGEs) | skin autofluorescence | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
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