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NCT Number: NCT06547515

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de recherche de l'IUCPQ

Québec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Claudia Gagnon, Dr

PRINCIPAL_INVESTIGATOR

Sandrine Hegg-Deloye

CONTACT

[email protected]

418-525-4444 ext. 48729

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

Sleeve gastrectomy

Primary outcomes

  1. Change in vBMD at the spine (L2-L3) and proximal femur

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by QCT

  2. Change in muscle mass at mid-femur

    Time frame: before, 1 year after and 3 years after bariatric surgery

    determined by measuring cross-sectional area at mid-femur (CT)

Secondary outcomes

  1. Change in vBMD at skeletal sites other than the spine

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by QCT

  2. Change in aBMD at skeletal sites

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by DXA

  3. Change in whole body muscle mass

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by DXA

  4. Change in muscle quality at mid-femur

    Time frame: before, 1 year after and 3 years after bariatric surgery

    muscle fat infiltration, using CT attenuation in Hounsfield unit (HU)

  5. Change in muscle strength

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by CT

  6. Change in upper extremity muscle strength

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by hand grip strength

  7. Change in lower extremity muscle strength

    Time frame: before, 1 year after and 3 years after bariatric surgery

    knee extensor strength

  8. Change in muscle mass (muscle cross-sectional area) and function

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by timed up and go test

  9. Change in muscle mass (muscle cross-sectional area) and function

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by 6-minute walk test

Other outcomes

  1. The clinical impact of SG on self-reported falls

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by self-reported questionnaire (yes/No)

  2. The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by questionnaire (yes/No and number of fractures, how)

  3. The proportion of participants meeting the recommendations for physical activity

    Time frame: before, 1 year after and 3 years after bariatric surgery

    by international physical activity questionnaire short version (score in MET-min/week), (Min 495 MET-minute/week, Max 1200 MET-minute/week)

  4. The proportion of participants meeting the recommendations for dietary protein intake

    Time frame: before, 1 year after and 3 years after bariatric surgery

    Dietary journal, Calculating macronutrient and micronutrient intake per day 3 web-based 24-h recalls

  5. The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements

    Time frame: before, 1 year after and 3 years after bariatric surgery

    serum D vitamin (25ODH) in blood sample

  6. The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements

    Time frame: before, 1 year after and 3 years after bariatric surgery

    Parathyroid hormone (PTH) in blood sample

  7. Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by blood sample. unit: micro g/l

  8. Changes in calcium,

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by blood sample. unit: mmol/l

  9. Changes in albumin,

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by blood sample. unit:g/l

  10. Changes in creatinin

    Time frame: before, 1 year after and 3 years after bariatric surgery

    assessed by blood sample. unit: micromol/l

  11. Changes in folliculo-stimulant (FSH)

    Time frame: FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine Hegg-Deloye, PhD

CONTACT

[email protected]

4185254444 ext. 48729

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

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

Registry information

Acronym: BONUS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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