Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
NCT Number: NCT06547515
Acronym: BONUS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bariatric Surgery|Bone Health|Severe Obesity|Muscle Health
Interventions: PROCEDURE: Bariatric surgery
Sponsor: CHU de Quebec-Universite Laval
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre|Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-14
Completion Date: 2026-08-15
Locations: Centre de recherche de l'IUCPQ, Québec, G1V 4G5, Canada

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.

Primary Outcome Measures: Change in vBMD at the spine (L2-L3) and proximal femur, assessed by QCT, before, 1 year after and 3 years after bariatric surgery|Change in muscle mass at mid-femur, determined by measuring cross-sectional area at mid-femur (CT), before, 1 year after and 3 years after bariatric surgery
Secondary Outcome Measures: Change in vBMD at skeletal sites other than the spine, assessed by QCT, before, 1 year after and 3 years after bariatric surgery|Change in aBMD at skeletal sites, assessed by DXA, before, 1 year after and 3 years after bariatric surgery|Change in whole body muscle mass, assessed by DXA, before, 1 year after and 3 years after bariatric surgery|Change in muscle quality at mid-femur, muscle fat infiltration, using CT attenuation in Hounsfield unit (HU), before, 1 year after and 3 years after bariatric surgery|Change in muscle strength, assessed by CT, before, 1 year after and 3 years after bariatric surgery|Change in upper extremity muscle strength, by hand grip strength, before, 1 year after and 3 years after bariatric surgery|Change in lower extremity muscle strength, knee extensor strength, before, 1 year after and 3 years after bariatric surgery|Change in muscle mass (muscle cross-sectional area) and function, by timed up and go test, before, 1 year after and 3 years after bariatric surgery|Change in muscle mass (muscle cross-sectional area) and function, by 6-minute walk test, before, 1 year after and 3 years after bariatric surgery
Other Outcome Measures: The clinical impact of SG on self-reported falls, by self-reported questionnaire (yes/No), before, 1 year after and 3 years after bariatric surgery|The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures, by questionnaire (yes/No and number of fractures, how), before, 1 year after and 3 years after bariatric surgery|The proportion of participants meeting the recommendations for physical activity, by international physical activity questionnaire short version (score in MET-min/week), (Min 495 MET-minute/week, Max 1200 MET-minute/week), before, 1 year after and 3 years after bariatric surgery|The proportion of participants meeting the recommendations for dietary protein intake, Dietary journal, Calculating macronutrient and micronutrient intake per day 3 web-based 24-h recalls, before, 1 year after and 3 years after bariatric surgery|The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements, serum D vitamin (25ODH) in blood sample, before, 1 year after and 3 years after bariatric surgery|The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements, Parathyroid hormone (PTH) in blood sample, before, 1 year after and 3 years after bariatric surgery|Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin, assessed by blood sample. unit: micro g/l, before, 1 year after and 3 years after bariatric surgery|Changes in calcium,, assessed by blood sample. unit: mmol/l, before, 1 year after and 3 years after bariatric surgery|Changes in albumin,, assessed by blood sample. unit:g/l, before, 1 year after and 3 years after bariatric surgery|Changes in creatinin, assessed by blood sample. unit: micromol/l, before, 1 year after and 3 years after bariatric surgery|Changes in folliculo-stimulant (FSH), 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., FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery.