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Search / Trial NCT06547515

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

Launched by CHU DE QUEBEC-UNIVERSITE LAVAL · Aug 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Bariatric Surgery Bone Health Severe Obesity Muscle Health

ClinConnect Summary

This clinical trial is studying the effects of sleeve gastrectomy (SG), a type of weight-loss surgery, on bone and muscle health in men and women. The researchers want to find out if people who have this surgery will experience changes in bone density and muscle mass over three years compared to those who do not have the surgery. This is important because while SG is effective for weight loss, there are concerns that it may also lead to bone and muscle loss, which can increase the risk of fractures and falls.

To participate in this trial, you need to be at least 18 years old and either planning to have sleeve gastrectomy or meet the criteria for the surgery but not going through with it. This includes men, premenopausal women, and postmenopausal women. Participants will undergo various tests to measure their bone and muscle health over the study period. If you’re interested, it’s a great opportunity to contribute to important research that could help improve understanding of the long-term effects of weight-loss surgery on bone and muscle health.

Gender

ALL

Eligibility criteria

  • 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.

About Chu De Quebec Universite Laval

CHU de Québec-Université Laval is a leading academic health center in Canada, renowned for its commitment to advancing medical research and improving patient care. As a prominent clinical trial sponsor, it leverages its extensive network of healthcare professionals, researchers, and state-of-the-art facilities to conduct innovative clinical studies across various therapeutic areas. With a strong emphasis on collaboration and ethical standards, CHU de Québec-Université Laval aims to translate scientific discoveries into effective treatments, enhancing health outcomes for diverse populations.

Locations

Québec, , Canada

Patients applied

0 patients applied

Trial Officials

Claudia Gagnon, Dr

Principal Investigator

CHU de Québec - Université Laval

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported