Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric surgery.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery, Bone Health, Severe Obesity, Muscle Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Bariatric surgery
Sleeve gastrectomy
Primary outcome measures
- Change in vBMD at the spine (L2-L3) and proximal femur [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in muscle mass at mid-femur [Time frame: before, 1 year after and 3 years after bariatric surgery]
Secondary outcome measures (9)
- Change in vBMD at skeletal sites other than the spine [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in aBMD at skeletal sites [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in whole body muscle mass [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in muscle quality at mid-femur [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in muscle strength [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in upper extremity muscle strength [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in lower extremity muscle strength [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in muscle mass (muscle cross-sectional area) and function [Time frame: before, 1 year after and 3 years after bariatric surgery]
- Change in muscle mass (muscle cross-sectional area) and function [Time frame: before, 1 year after and 3 years after bariatric surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Centre de recherche de l'IUCPQ — Québec
Identifiers
NCT: NCT06547515 · MP-10-2022-3823