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

Osteoarthritis, Knee Clinical Trial

— MEDADIPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03678831
• Other study ID #: 2017_59
• Secondary ID: 2018-A00660-55
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: August 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Gilles Pasquier, MD,PhD
• Phone: 3.20.44.66.06
• Email: gilles.pasquier[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Prosthesis User

Intervention

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

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	MSDAVENIR Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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	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