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| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy diabetes | 70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy |
| |
| Control without obesity or diabetes | 30 Men and women who are overweight (without obesity) and without diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated) |
| Measure | Description | Time Frame |
|---|---|---|
| Bone microarchitecture and metabolism | by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry | during surgery |
| Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5) |
Inclusion Criteria:
Exclusion Criteria:
Control group: Same criteria plus: >5% change in weight in the last 3 months; pregnancy or lactation in the last year.
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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).
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Chouinard-Castonguay | Contact | 4185254444 | 48729 | Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Gagnon, Dr | CHU de Québec - Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Institute of the McGill University Health Centre | Terminated | Montreal | Quebec | H3H 2R9 | Canada | |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Blood (serum and plasma)
serum bone formation marker |
| before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| 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 |
| Change in C-telopeptide | serum bone resorption marker | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| Change in fasting glucose | diabetes control | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| Change in HbA1c | diabetes control | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in sclerostin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| Change in adiponectin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| Change in leptin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| 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 |
| Change in ghrelin | hormones involved in bone metabolism | before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery |
| 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 |
| 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 |
| 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 |
| Change in fat and lean mass | body composition assessed by bioimpedance and by DXA | before, 1 year after and 3 years after bariatric surgery |
| Change in visceral and subcutaneous adipose tissue | body composition assessed by computed tomography (CT) | before, 1 year after and 3 years after bariatric surgery |
| 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 |
| Change in upper extremity muscle strength | assessed by hand grip strength | before, 1 year after and 3 years after bariatric surgery |
| Change in lower extremity muscle strength | assessed by knee extensor strength | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle function | assessed by timed up and go test | before, 1 year after and 3 years after bariatric surgery |
| Change in physical capacity | assessed by 6-minute walk test | before, 1 year after and 3 years after bariatric surgery |
| Change in balance | assessed by Fullerton Advanced Balance (FAB) Scale | before and 1 year after bariatric surgery |
| Change in sociodemographic factors | questionnaire | before, 1 year after and 3 years after bariatric surgery |
| 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 |
| 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 |
| Change in measured physical activity level | by accelerometer | before, 1 year after and 3 years after bariatric surgery |
| Change in gut microbiota | stool sample | before, 1 year after and 3 years after bariatric surgery |
| 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 |
Using the algorithm-based qualitative method (ABQ) and the Genant method
| before, 1 year after and 3 years after bariatric surgery |
| Prevalence and incidence of falls | by questionnaire | before, 1 year after and 3 years after bariatric surgery |
| Prevalence and incidence of non-vertebral fractures | by questionnaire (self-reported) | before, 1 year after and 3 years after bariatric surgery |
| Centre de recherche du CHU de Québec - Université Laval |
| Active, not recruiting |
| Québec |
| Quebec |
| G1V 4G2 |
| Canada |
| Centre de recherche de l'IUCPQ | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |