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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03678831

Collaborator

MSDAVENIR Foundation (Other)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Prosthesis User	Procedure: tissue

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2020

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 [at 3 months]

Secondary Outcome Measures

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 [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 [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 [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.
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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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