Bariatric Surgery, Bone Health, Diabetes Mellitus, Type 2, Obesity, Morbid
Conditions
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 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.
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 before and at 4 months, 8 months, one year and 3 years after surgery in the bariatric groups and at a single visit for the control group. Bariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.
Interventions
PROCEDUREBariatric surgery
Sleeve gastrectomy
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
CHU de Quebec-Universite Laval
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius | before, 1 year after and 3 years after bariatric surgery | assessed by quantitative computed tomography (QCT) |
| Change in areal bone mineral density at lumbar spine, hip and radius | before, 1 year after and 3 years after bariatric surgery | assessed by dual-energy X-ray absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in peptide YY (PYY) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in self-reported physical activity level | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | by questionnaire |
| Change in measured physical activity level | before, 1 year after and 3 years after bariatric surgery | by accelerometer |
| Change in gut microbiota | before, 1 year after and 3 years after bariatric surgery | stool sample |
| Change in cutaneous Advanced glycation end products (AGEs) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | skin autofluorescence |
| Change in N-terminal propeptide of type 1 procollagen (P1NP) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | serum bone formation marker |
| Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | serum bone formation marker |
| Change in bone alkaline phosphatase | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | serum bone formation marker |
| Change in C-telopeptide | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | serum bone resorption marker |
| Change in fasting glucose | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | diabetes control |
| Change in HbA1c | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | diabetes control |
| Change in fasting insulin | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in serum 25-hydroxyvitamin D | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in parathormone (PTH) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in estradiol and estrone | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in insulin like growth factor (IGF)-1 | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in sclerostin | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in adiponectin | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in leptin | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in sociodemographic factors | before, 1 year after and 3 years after bariatric surgery | questionnaire |
| Change in ghrelin | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in oxidative stress markers | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in serum advanced glycation end products (AGEs) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in Free fatty acids (FFA) | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | hormones involved in bone metabolism |
| Change in fat and lean mass | before, 1 year after and 3 years after bariatric surgery | body composition assessed by bioimpedance and by DXA |
| Change in visceral and subcutaneous adipose tissue | before, 1 year after and 3 years after bariatric surgery | body composition assessed by computed tomography (CT) |
| Change in muscle mass and fat content at mid-femur | before, 1 year after and 3 years after bariatric surgery | assessed by computed tomography (CT) |
| Change in upper extremity muscle strength | before, 1 year after and 3 years after bariatric surgery | assessed by hand grip strength |
| Change in lower extremity muscle strength | before, 1 year after and 3 years after bariatric surgery | assessed by knee extensor strength |
| Change in muscle function | before, 1 year after and 3 years after bariatric surgery | assessed by timed up and go test |
| Change in physical capacity | before, 1 year after and 3 years after bariatric surgery | assessed by 6-minute walk test |
| Change in balance | before and 1 year after bariatric surgery | assessed by Fullerton Advanced Balance (FAB) Scale |
| Change in nutrition | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery | 3 web-based 24-h recalls |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence and incidence of falls | before, 1 year after and 3 years after bariatric surgery | by questionnaire |
| Prevalence and incidence of non-vertebral fractures | before, 1 year after and 3 years after bariatric surgery | by questionnaire (self-reported) |
| Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5) | before, 1 year after and 3 years after bariatric surgery | Using the algorithm-based qualitative method (ABQ) and the Genant method |
| Bone microarchitecture and metabolism | during surgery | by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry |
Countries
Canada
Contacts
Primary ContactSarah Chouinard-Castonguay
Outcome results
None listed