Clinical trial NCT03678831: Characteristics of Marrow Fatty Cells in the Ageing of Bone and Joints, Osteoarthritis and Osteoporosis
Official title: Characterization of Bone Marrow Adipocytes in Osteoarthritic and Post-menopausal Patients: a Comparative Study With Adipocytes From Subcutaneous Adipose Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Prosthesis User
Keywords: Osteoarthritis
prosthetic surgery of the knee
obesity
type 2 diabetes
bone marrow fat
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: MSDAVENIR Foundation
First posted: 2018-09-20
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Arthritic post-menopausal patients with knee prosthetic replacement

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at 3 months
Secondary outcomes:
measure: 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
timeFrame: at 3 months
measure: 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
timeFrame: at 3 months
measure: 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
timeFrame: at 3 months
measure: 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
timeFrame: at 3 months
measure: 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
timeFrame: at 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Gilles Pasquier, MD
role: PRINCIPAL_INVESTIGATOR
References: