RecruitingNCT06547515

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


Sponsor

CHU de Quebec-Universite Laval

Enrollment

156 participants

Start Date

Sep 14, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBariatric surgery

Sleeve gastrectomy


Locations(1)

Centre de recherche de l'IUCPQ

Québec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06547515


Related Trials