Recruiting

Bone & Muscle Health

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT06547515

Conditions

Bariatric Surgery

Bone Health

Severe Obesity

Muscle Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bariatric surgery

Study Details

Brief 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.

Conditions

Bariatric Surgery

Bone Health

Severe Obesity

Muscle Health

Study ID

NCT06547515

Start date

Sep 14, 2022

Status verified date

Jun, 2025

Completion date

Aug 15, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

156 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Bariatric surgery

Sleeve gastrectomy

Primary outcome measure

  • Change in vBMD at the spine (L2-L3) and proximal femur [ Time Frame: before, 1 year after and 3 years after bariatric surgery ]
  • Change in muscle mass at mid-femur [ Time Frame: before, 1 year after and 3 years after bariatric surgery ]

Central Contacts and Locations

Central contacts

Locations

Centre de recherche de l'IUCPQ

Recruiting

Québec, Canada, G1V 4G5

Contacts

Principal Investigator:

Claudia Gagnon, Dr

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Keywords

  • bariatric surgery
  • Bone health
  • Severe Obesity
  • Muscle Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2025-06-10.