Clinical trial

Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women

Recruiting now · Not applicable · 1 countries · Registry ID NCT06547515

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionBariatric Surgery, Bone Health, Severe Obesity, Muscle Health

Full registry 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.

Treatments and study arms

Bariatric surgery

Procedure

Sleeve gastrectomy

Primary outcomes

Change in vBMD at the spine (L2-L3) and proximal femurbefore, 1 year after and 3 years after bariatric surgery

assessed by QCT

Change in muscle mass at mid-femurbefore, 1 year after and 3 years after bariatric surgery

determined by measuring cross-sectional area at mid-femur (CT)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Centre de recherche de l'IUCPQ🇨🇦 Québec, Canada

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Sandrine Hegg-DeloyeContact

Email · Call 418-525-4444

Claudia Gagnon, DrPrincipal Investigator