NCT05593640

Brief Summary

TXA2 inhibits the expression of the primary marker of thermogenesis (UCP1) while prostacyclin (PGI2), another metabolite derived from arachidonic acid, enhances its expression. Given the close relationship between the adipocyte and the chondrocyte, the study team hypothesises that thromboxane A2 controls chondrocyte formation and function and thus cartilage homeostasis. The study objectives are: i) to analyse the role of TXA2 on chondrocyte differentiation in vitro, ii) to determine the association between circulating and tissue TXA2 levels in a rat model of osteoarthritis, and iii) to correlate circulating and synovial fluid levels of TXA2 with the development of osteoarthritis in a small human cohort. The proposed research aims to better understand the mechanisms underlying the role of lipid metabolites in chondrocyte formation and function, paving the way for the development of nutritional and pharmacological therapies to combat OA and associated metabolic disorders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 20, 2022

Last Update Submit

October 20, 2022

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • to look for correlation between the rate of throboxane and the grade of osteoarthritis

    kellgren and lawrence classification

    6 months

Study Arms (1)

ThroboxaneOA

Patient with osteoarthritis and knee effusion

Other: biological samples

Interventions

biological samplesOTHER

blood and synovial liquid will be sampled

ThroboxaneOA

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with osteoarthritis and knee effusion

You may qualify if:

  • presence of knee osteoarthritis with effusion, , no inflammatory disease

You may not qualify if:

  • anticoagulant treatment
  • inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NICE

Nice, 06003, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, serum and synovial liquid

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Christian ROUX, MD, PhD

CONTACT

+33492035491roux.c2@chu-nice.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

not scheduled

Locations

FR(1)