BODI: Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sleeve gastrectomy diabetes 70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy |
Procedure: Bariatric surgery
Sleeve gastrectomy
|
| Control without obesity or diabetes 30 Men and women who are overweight (without obesity) and without diabetes |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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 ghrelin [before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
hormones involved in bone metabolism
- Oxidative stress markers [before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
hormones involved in bone metabolism
- 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
- 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 sociodemographic factors [before, 1 year after and 3 years after bariatric surgery]
questionnaire
- 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
- 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
Other Outcome Measures
- Bone microarchitecture and metabolism [during surgery]
by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry
- 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
- 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)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Research Institute of the McGill University Health Centre | Montréal | Quebec | Canada | H3H 2R9 |
| 2 | Centre de recherche du CHU de Québec - Université Laval | Quebec | Canada | G1V 4G2 | |
| 3 | Centre de recherche de l'IUCPQ | Québec | Canada | G1V 4G5 |
Sponsors and Collaborators
- CHU de Quebec-Universite Laval
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
- Principal Investigator: Claudia Gagnon, Dr, CHU de Québec - Université Laval
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MP-10-2018-2957