Bariatric Surgery, Bone Health, Muscle Health, Severe Obesity
Conditions
Keywords
bariatric surgery, Bone health, Severe Obesity, Muscle Health
Brief summary
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged \>18 years; * Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group. * Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) \>40 UI/L. * Women taking oral contraceptive pills or hormone replacement therapy * Patients with type 2 diabetes.
Exclusion criteria
* Type 1 diabetes; * Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder) * Metabolic bone disease other than osteoporosis or type 2 diabetes, * Creatinine clearance \<30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism; * Weight \>204 kg (DXA weight limit) or BMI \>60 kg/m2 (upper limit to allow for QCT examination); * Current or planned pregnancy during follow-up; breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vBMD at the spine (L2-L3) and proximal femur | before, 1 year after and 3 years after bariatric surgery | assessed by QCT |
| Change in muscle mass at mid-femur | before, 1 year after and 3 years after bariatric surgery | determined by measuring cross-sectional area at mid-femur (CT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength | before, 1 year after and 3 years after bariatric surgery | assessed by CT |
| Change in upper extremity muscle strength | before, 1 year after and 3 years after bariatric surgery | by hand grip strength |
| Change in lower extremity muscle strength | before, 1 year after and 3 years after bariatric surgery | knee extensor strength |
| Change in whole body muscle mass | before, 1 year after and 3 years after bariatric surgery | assessed by DXA |
| Change in muscle quality at mid-femur | before, 1 year after and 3 years after bariatric surgery | muscle fat infiltration, using CT attenuation in Hounsfield unit (HU) |
| Change in vBMD at skeletal sites other than the spine | before, 1 year after and 3 years after bariatric surgery | assessed by QCT |
| Change in aBMD at skeletal sites | before, 1 year after and 3 years after bariatric surgery | assessed by DXA |
| Change in muscle mass (muscle cross-sectional area) and function | before, 1 year after and 3 years after bariatric surgery | by timed up and go test |
Other
| Measure | Time frame | Description |
|---|---|---|
| The clinical impact of SG on self-reported falls | before, 1 year after and 3 years after bariatric surgery | by self-reported questionnaire (yes/No) |
| The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures | before, 1 year after and 3 years after bariatric surgery | by questionnaire (yes/No and number of fractures, how) |
| The proportion of participants meeting the recommendations for physical activity | before, 1 year after and 3 years after bariatric surgery | by international physical activity questionnaire short version (score in MET-min/week), (Min 495 MET-minute/week, Max 1200 MET-minute/week) |
| The proportion of participants meeting the recommendations for dietary protein intake | before, 1 year after and 3 years after bariatric surgery | Dietary journal, Calculating macronutrient and micronutrient intake per day 3 web-based 24-h recalls |
| The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements | before, 1 year after and 3 years after bariatric surgery | serum D vitamin (25ODH) in blood sample |
| Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin | before, 1 year after and 3 years after bariatric surgery | assessed by blood sample. unit: micro g/l |
| Changes in calcium, | before, 1 year after and 3 years after bariatric surgery | assessed by blood sample. unit: mmol/l |
| Changes in albumin, | before, 1 year after and 3 years after bariatric surgery | assessed by blood sample. unit:g/l |
| Changes in creatinin | before, 1 year after and 3 years after bariatric surgery | assessed by blood sample. unit: micromol/l |
| Changes in folliculo-stimulant (FSH) | FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery. | assessed by blood sample. unit: UI/l FSH will help categorize hysterectomized women or those with non-menopausal amenorrhea. Premenopause will be defined as menses in the last year. |
Countries
Canada
Contacts
Primary ContactSandrine Hegg-Deloye, PhD
Outcome results
None listed