An observational study in Bariatric Surgery, Bone Health and Severe Obesity, sponsored by CHU de Quebec-Universite Laval. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by CHU de Quebec-Universite Laval · Observational
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's planned enrollment of 156 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a multicentre, prospective and observational study comprising a SG bariatric group undergoing SG (n=117) comprising an equal number of men, premenopausal and postmenopausal women (n=39/group) meeting the inclusion/exclusion criteria, and assessed before, and at one and 3 years after SG. An obese non-surgical group (n=39; 13 men, premenopausal and postmenopausal women) meeting the criteria for SG but who will not undergo surgery during the 3-year period following recruitment will be assessed using the same tests and at the same timepoints.
Exclusion Criteria:
n = 39 men with obesity undergoing sleeve gastrectomy
Procedure: Bariatric surgery
n = 39 premenopausal women with obesity undergoing sleeve gastrectomy
Procedure: Bariatric surgery
n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy
Procedure: Bariatric surgery
n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals
Sleeve gastrectomy
Change in vBMD at the spine (L2-L3) and proximal femur
assessed by QCT
Time frame: 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)
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in vBMD at skeletal sites other than the spine
assessed by QCT
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in aBMD at skeletal sites
assessed by DXA
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in whole body muscle mass
assessed by DXA
Time frame: 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)
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in muscle strength
assessed by CT
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength
by hand grip strength
Time frame: before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength
knee extensor strength
Time frame: 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
Time frame: 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
Time frame: before, 1 year after and 3 years after bariatric surgery
The clinical impact of SG on self-reported falls
by self-reported questionnaire (yes/No)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before, 1 year after and 3 years after bariatric surgery
Changes in calcium,
assessed by blood sample. unit: mmol/l
Time frame: before, 1 year after and 3 years after bariatric surgery
Changes in albumin,
assessed by blood sample. unit:g/l
Time frame: before, 1 year after and 3 years after bariatric surgery
Changes in creatinin
assessed by blood sample. unit: micromol/l
Time frame: 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.
Time frame: FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CHU de Quebec-Universite Laval