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

NCT06547515 | Recruiting

• 1 other identifier: MP-10-2022-3823
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

bariatric surgery; Bone health; Severe Obesity; Muscle Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in vBMD at skeletal sites other than the spine

  before, 1 year after and 3 years after bariatric surgery

• Change in aBMD at skeletal sites

  before, 1 year after and 3 years after bariatric surgery

• Change in whole body muscle mass

  before, 1 year after and 3 years after bariatric surgery

• Change in muscle quality at mid-femur

  before, 1 year after and 3 years after bariatric surgery

• Change in muscle strength

  before, 1 year after and 3 years after bariatric surgery

Other Outcomes (11)

• The clinical impact of SG on self-reported falls

  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

  before, 1 year after and 3 years after bariatric surgery

• The proportion of participants meeting the recommendations for physical activity

  before, 1 year after and 3 years after bariatric surgery

Study Arms (4)

Sleeve gastrectomy - Men

n = 39 men with obesity undergoing sleeve gastrectomy

Procedure: Bariatric surgery

Sleeve gastrectomy - Premenopausal women

n = 39 premenopausal women with obesity undergoing sleeve gastrectomy

Procedure: Bariatric surgery

Sleeve gastrectomy - Postmenopausal women

n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy

Procedure: Bariatric surgery

Obese non-surgical group

n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals

Interventions

Bariatric surgery PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy - Men; Sleeve gastrectomy - Postmenopausal women; Sleeve gastrectomy - Premenopausal women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender role has been shown to influence lifestyle behaviours such as physical activity and nutrition. It is however unknown whether gender role influences adherence to the American Society for Metabolic and Bariatric Surgery physical activity and dietary intake/supplement recommendations that are important for bone/muscle health after bariatric surgery. A short questionnaire, the validated 12-item Bem Sex Role Inventory, will be administered to the participants to categorize them into 4 gender role categories. In an exploratory descriptive analysis, the investigators will calculate the proportion of participants in each gender role category meeting the dietary/supplement intake and physical activity recommendations and document the type and amount of physical activity they perform.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Centre de recherche de l'IUCPQ

Québec, G1V 4G5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma)

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Claudia Gagnon, Dr

  CHU de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine Hegg-Deloye, PhD

CONTACT

4185254444; sandrine.hegg-deloye@crchudequebec.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Endocrinologist, Regular Researcher of the Endocrinology-Nephrology Axis

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 9, 2024
• Study Start: September 14, 2022
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CA (1)