Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Bone HealthBariatric SurgeryObesity, Morbid
- Interventions
- Procedure: Bariatric surgery
- Registration Number
- NCT03455868
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sleeve gastrectomy diabetes Bariatric surgery 70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy
- Primary Outcome Measures
Name Time Method 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)
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)
- Secondary Outcome Measures
Name Time Method Change in HbA1c before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery diabetes control
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 sclerostin 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 measured physical activity level before, 1 year after and 3 years after bariatric surgery by accelerometer
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 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 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 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 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 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 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 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 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 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 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 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 muscle function before, 1 year after and 3 years after bariatric surgery assessed by timed up and go test
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 ghrelin before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery hormones involved in bone metabolism
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 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 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 lower extremity muscle strength before, 1 year after and 3 years after bariatric surgery assessed by knee extensor strength
Trial Locations
- Locations (3)
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, Canada