Centre de recherche de l'IUCPQ
Québec, G1V 4G5, Canada
Location status: Recruiting
NCT Number: NCT06547515
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Québec, G1V 4G5, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleeve gastrectomy
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by QCT
Time frame: before, 1 year after and 3 years after bariatric surgery
determined by measuring cross-sectional area at mid-femur (CT)
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by QCT
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by DXA
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by DXA
Time frame: before, 1 year after and 3 years after bariatric surgery
muscle fat infiltration, using CT attenuation in Hounsfield unit (HU)
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by CT
Time frame: before, 1 year after and 3 years after bariatric surgery
by hand grip strength
Time frame: before, 1 year after and 3 years after bariatric surgery
knee extensor strength
Time frame: before, 1 year after and 3 years after bariatric surgery
by timed up and go test
Time frame: before, 1 year after and 3 years after bariatric surgery
by 6-minute walk test
Time frame: before, 1 year after and 3 years after bariatric surgery
by self-reported questionnaire (yes/No)
Time frame: before, 1 year after and 3 years after bariatric surgery
by questionnaire (yes/No and number of fractures, how)
Time frame: 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)
Time frame: 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
Time frame: before, 1 year after and 3 years after bariatric surgery
serum D vitamin (25ODH) in blood sample
Time frame: before, 1 year after and 3 years after bariatric surgery
Parathyroid hormone (PTH) in blood sample
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by blood sample. unit: micro g/l
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by blood sample. unit: mmol/l
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by blood sample. unit:g/l
Time frame: before, 1 year after and 3 years after bariatric surgery
assessed by blood sample. unit: micromol/l
Time frame: 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.
Contact information is provided by the study sponsor or research team.
CHU de Quebec-Universite Laval
Other
Acronym: BONUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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