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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Bariatric surgery

Treatment groups

156 Participants
are divided into 4 treatment groups

Sponsors and collaborators

CHU de Quebec-Universite Laval

Lead sponsor

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

Collaborator