Actively Recruiting

Age: 18Years +
All Genders
NCT06547515

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

Led by CHU de Quebec-Universite Laval · Updated on 2025-06-10

156

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

C

CHU de Quebec-Universite Laval

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged >18 years
  • Awaiting sleeve gastrectomy for the bariatric group or meeting criteria for sleeve gastrectomy but not having surgery for the non-surgical group
  • Menopause defined as absence of menses for a year and serum follicular-stimulating hormone (FSH) >40 UI/L
  • Women using oral contraceptive pills or hormone replacement therapy
  • Patients with type 2 diabetes
Not Eligible

You will not qualify if you...

  • Type 1 diabetes
  • Uncontrolled thyroid disease or overt inflammatory disorder
  • Metabolic bone disease other than osteoporosis or type 2 diabetes
  • Creatinine clearance <30 ml/min
  • Use of medications affecting bone metabolism such as glucocorticoids, anti-epileptic drugs, osteoporosis therapy, or thiazolidinediones
  • Weight over 204 kg or body mass index over 60 kg/m2
  • Current or planned pregnancy during follow-up or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre de recherche de l'IUCPQ

Québec, Canada, G1V 4G5

Actively Recruiting

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Research Team

S

Sandrine Hegg-Deloye, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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