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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centre de recherche de l'IUCPQ
RECRUITING
Québec
Contact Information
Primary
Sandrine Hegg-Deloye, PhD
sandrine.hegg-deloye@crchudequebec.ulaval.ca
4185254444
Time Frame
Start Date: 2022-09-14
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 156
Treatments
Sleeve gastrectomy - Men
n = 39 men with obesity undergoing sleeve gastrectomy
Sleeve gastrectomy - Premenopausal women
n = 39 premenopausal women with obesity undergoing sleeve gastrectomy
Sleeve gastrectomy - Postmenopausal women
n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy
Obese non-surgical group
n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals
Sponsors
Leads: CHU de Quebec-Universite Laval
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

This content was sourced from clinicaltrials.gov

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