Actively Recruiting

Age: 45Years - 70Years
FEMALE
NCT05005039

Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss

Led by University Hospital, Lille · Updated on 2026-04-20

40

Participants Needed

1

Research Sites

266 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant. The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH…), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.

CONDITIONS

Official Title

Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss

Who Can Participate

Age: 45Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women (last menses more than 12 months ago)
  • Obesity with a BMI of 35 kg/m8 or higher
  • Indication for bariatric surgery, with planned RYGB or SG procedure
  • No previous bariatric surgery
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of osteoporotic fracture
  • Current or recent corticosteroid therapy within past 3 months
  • Conditions or treatments affecting bone metabolism (e.g., breast cancer with aromatase inhibitors, malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism)
  • History of radiation therapy to lumbar spine or hip
  • Use of hormone replacement therapy or anti-osteoporotic treatments other than calcium or vitamin D
  • Chronic kidney disease with creatinine clearance 4 mL/min
  • Weight over 160 kg
  • Previous bariatric surgery
  • Orthopedic implants in both hips or lumbar spine
  • Unable to give personal consent
  • Under legal guardianship or conservatorship
  • Not enrolled in a social security program
  • Contraindications to MRI (e.g., claustrophobia, pacemaker, cochlear implant, neurostimulator, orthopedic implants in hip, pelvis, or lumbar spine)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hopital Roger Salengro, CHU Lille

Lille, France

Actively Recruiting

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Research Team

J

Julien PACCOU, MD,PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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