Clinical trial NCT06547515: Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Official title: Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Bone Health
Severe Obesity
Muscle Health
Keywords: bariatric surgery
Bone health
Severe Obesity
Muscle Health
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2024-08-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in vBMD at the spine (L2-L3) and proximal femur
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle mass at mid-femur
timeFrame: before, 1 year after and 3 years after bariatric surgery
Secondary outcomes:
measure: Change in vBMD at skeletal sites other than the spine
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in aBMD at skeletal sites
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in whole body muscle mass
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle quality at mid-femur
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle strength
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in upper extremity muscle strength
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in lower extremity muscle strength
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle mass (muscle cross-sectional area) and function
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle mass (muscle cross-sectional area) and function
timeFrame: before, 1 year after and 3 years after bariatric surgery
Other outcomes:
measure: The clinical impact of SG on self-reported falls
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: The proportion of participants meeting the recommendations for physical activity
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: The proportion of participants meeting the recommendations for dietary protein intake
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Changes in calcium,
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Changes in albumin,
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Changes in creatinin
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Changes in folliculo-stimulant (FSH)
timeFrame: FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery.
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'IUCPQ
Study officials:
affiliation: CHU de Québec - Université Laval
name: Claudia Gagnon, Dr
role: PRINCIPAL_INVESTIGATOR
References: