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

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery; Bone Health; Severe Obesity; Muscle Health
• Intervention / Treatment: Procedure: Bariatric surgery

• Study Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Sandrine Hegg-Deloye, PhD; Phone Number: 48729 4185254444; Email: sandrine.hegg-deloye@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Recruiting
    • Centre de recherche de l'IUCPQ
    • Principal Investigator: Claudia Gagnon, Dr
    • Contact: Sandrine Hegg-Deloye; Phone Number: 48729 418-525-4444; Email: sandrine-hegg-deloye@crchudequebec.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleeve gastrectomy - Men; n = 39 men with obesity undergoing sleeve gastrectomy	Procedure: Bariatric surgery; Sleeve gastrectomy
Sleeve gastrectomy - Premenopausal women; n = 39 premenopausal women with obesity undergoing sleeve gastrectomy	Procedure: Bariatric surgery; Sleeve gastrectomy
Sleeve gastrectomy - Postmenopausal women; n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy	Procedure: Bariatric surgery; Sleeve gastrectomy
Obese non-surgical group; n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vBMD at the spine (L2-L3) and proximal femur	assessed by QCT	before, 1 year after and 3 years after bariatric surgery
Change in muscle mass at mid-femur	determined by measuring cross-sectional area at mid-femur (CT)	before, 1 year after and 3 years after bariatric surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vBMD at skeletal sites other than the spine	assessed by QCT	before, 1 year after and 3 years after bariatric surgery
Change in aBMD at skeletal sites	assessed by DXA	before, 1 year after and 3 years after bariatric surgery
Change in whole body muscle mass	assessed by DXA	before, 1 year after and 3 years after bariatric surgery
Change in muscle quality at mid-femur	muscle fat infiltration, using CT attenuation in Hounsfield unit (HU)	before, 1 year after and 3 years after bariatric surgery
Change in muscle strength	assessed by CT	before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength	by hand grip strength	before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength	knee extensor strength	before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function	by timed up and go test	before, 1 year after and 3 years after bariatric surgery
Change in muscle mass (muscle cross-sectional area) and function	by 6-minute walk test	before, 1 year after and 3 years after bariatric surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical impact of SG on self-reported falls	by self-reported questionnaire (yes/No)	before, 1 year after and 3 years after bariatric surgery
The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures	by questionnaire (yes/No and number of fractures, how)	before, 1 year after and 3 years after bariatric surgery
The proportion of participants meeting the recommendations for physical activity	by international physical activity questionnaire short version (score in MET-min/week), (Min 495 MET-minute/week, Max 1200 MET-minute/week)	before, 1 year after and 3 years after bariatric surgery
The proportion of participants meeting the recommendations for dietary protein intake	Dietary journal, Calculating macronutrient and micronutrient intake per day 3 web-based 24-h recalls	before, 1 year after and 3 years after bariatric surgery
The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements	serum D vitamin (25ODH) in blood sample	before, 1 year after and 3 years after bariatric surgery
The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements	Parathyroid hormone (PTH) in blood sample	before, 1 year after and 3 years after bariatric surgery
Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin	assessed by blood sample. unit: micro g/l	before, 1 year after and 3 years after bariatric surgery
Changes in calcium,	assessed by blood sample. unit: mmol/l	before, 1 year after and 3 years after bariatric surgery
Changes in albumin,	assessed by blood sample. unit:g/l	before, 1 year after and 3 years after bariatric surgery
Changes in creatinin	assessed by blood sample. unit: micromol/l	before, 1 year after and 3 years after bariatric surgery
Changes in folliculo-stimulant (FSH)	assessed by blood sample. unit: UI/l FSH will help categorize hysterectomized women or those with non-menopausal amenorrhea. Premenopause will be defined as menses in the last year.	FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery.

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Claudia Gagnon, Dr, CHU de Québec - Université Laval

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: bariatric surgery; Bone health; Severe Obesity; Muscle Health
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: MP-10-2022-3823

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No