Characteristics of Marrow Fatty Cells in the Ageing of Bone and Joints, Osteoarthritis and Osteoporosis (MEDADIPO)

December 4, 2025 updated by: University Hospital, Lille

Characterization of Bone Marrow Adipocytes in Osteoarthritic and Post-menopausal Patients: a Comparative Study With Adipocytes From Subcutaneous Adipose Tissue

Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage.

The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hopital Roger Salengro, CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Arthritic post-menopausal patients with knee prosthetic replacement

Description

Inclusion Criteria:

  • Post-menopausal woman
  • with a symptomatic knee osteoarthritis requiring prosthesis
  • able to handle general anaesthesia
  • having given her consent
  • able to understand the constraints associated with the study
  • with health insurance
  • able to understand the French language

Exclusion Criteria:

  • with refusal to participate to the study
  • more than 85-year-old
  • with bone pathologies other than osteoarthritis or osteoporosis
  • with active infection
  • with evolving cancer
  • with haematopoietic pathologies such as haemoglobin pathologies
  • with thyroid pathologies
  • with type 1 diabetes
  • with anti-osteoporotic treatments (bisphosphonates, strontium ranelate, teriparatide, denosumab) except calcium and vitamin D supplementation or hormone replacement.
  • with replacement of prosthesis

  • with previous surgery at the surgery site

    --with a current participation to another study

  • with guardianship
  • with deprived liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arthritic patients with knee prosthetic replace
Arthritic post-menopausal patients with knee prosthetic replacement Each patient is her own control since the two cell types are compared within the same patient The main criteria is based on a comparison of two cell types from the same patient. The secondary criteria are based on a comparison of cell types according to a grouping of patients according to different metabolic parameters.
Procedure: tissue
Adipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression levels in femoral spinal adipocytes of mRNAs of 18 genes compared to those of adipocytes isolated from the subcutaneous adipose tissue in the same patient
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Obesity state (normal vs overweight vs obese) as defined using BMI
Time Frame: at 3 months
at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Central obesity (yes or no) as defined using the waist-to-hip ratio
Time Frame: at 3 months
at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Presence or absence of systemic insulin-resistance as measured using the HOMA-IR index
Time Frame: at 3 months
the Homeostatic Model Assessment of Insulin Resistance(HOMA-IR index)Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytesaccording to Presence or absence of chronic uncontrolled hyperglycaemia as measured using HbA1c plasma levels
Time Frame: at 3 months
at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to presence or absence of metabolic syndrome
Time Frame: at 3 months
metabolic syndrome as defined by the presence of at least three of the following criteria: large waist circumference, decrease in HDL-cholesterol, hypertriglyceridemia, elevated fasting glycaemia, elevated blood pressure.
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

MSDAVENIR Foundation

Investigators

  • Principal Investigator: Gilles Pasquier, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

March 11, 2024

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 20, 2018

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_59
  • 2018-A00660-55 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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