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

ConditionsBariatric Surgery Bone Health Severe Obesity Muscle Health

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

This trial does not accept healthy volunteers

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 population

This is a multicentre, prospective and observational study comprising a SG bariatric group undergoing SG (n=117) comprising an equal number of men, premenopausal and postmenopausal women (n=39/group) meeting the inclusion/exclusion criteria, and assessed before, and at one and 3 years after SG. An obese non-surgical group (n=39; 13 men, premenopausal and postmenopausal women) meeting the criteria for SG but who will not undergo surgery during the 3-year period following recruitment will be assessed using the same tests and at the same timepoints.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Bariatric surgery
Procedure/Surgery
Sleeve gastrectomy

Treatment groups

156 Participants

are divided into 4 treatment groups

Group A: Sleeve gastrectomy - Men1 intervention

Group B: Sleeve gastrectomy - Premenopausal women1 intervention

Group C: Sleeve gastrectomy - Postmenopausal women1 intervention

Group D: Obese non-surgical group0 interventions

Trial outcomes