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NCT Number: NCT03678831

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prosthesis User Rheumatic Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

tissue

Procedure

Adipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • MSDAVENIR Foundation

Registry information

Official study title

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

Acronym: MEDADIPO

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2018
Registry last updated
Dec 5, 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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