Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis
ADIPSO
1 other identifier
interventional
199
1 country
1
Brief Summary
Body composition analysis and especially body fat distribution in regions of interest (android and in particular intra-abdominal region) provides some information on the risk of cardiovascular disease. There is little data available on the body composition analysis in psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in particular data on fat distribution in regions of interest regarding the risk of cardiovascular disease. Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic properties that are interesting to explore in pathologies with a higher risk of cardiovascular disease like psoriasis or psoriatic arthritis. Adipokines have been investigated in psoriasis but fat tissue and in particular its distribution (android/visceral or intra-abdominal) has not been studied in parallel. Moreover, relation between adipokines and psoriasis area or severity has been studied but the relation between adipokines and cardiovascular risk factors has not yet been investigated. The aim of this study is to investigate relations between the body fat distribution, adipokines rates and the risk of cardiovascular disease of these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
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
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2017
CompletedFebruary 12, 2018
February 1, 2018
3.5 years
July 27, 2016
February 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
day 1
Secondary Outcomes (9)
Body fat
day 1
body masses
day 1
Intra-abdominal body fat mass (measured by CoreScan)
day 1
Gynoid distribution of body fat
day 1
SCORE (Systematic COronary Risk Evaluation).
day 1
- +4 more secondary outcomes
Study Arms (1)
Psoriasis and arthritic psoriasis
EXPERIMENTALadditional blood sample for biological analyses bone densitometry questionnaires
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of psoriasis vulgaris or psoriasis pustulosa confirmed by a dermatologist or a diagnosis of psoriatic arthritis (CASPAR criteria) confirmed by a rheumatologist
- Age ≥ 18 and ≤ 80 years old
- Control group: patients matching with sex, age ± 5 years, BMI (4 groups), coming to the same hospital for a consultation.
- (BMI groups : BMI \< 18,5 kg/m²; 18,5 ≤ BMI ≤ 24,99 kg/m²; 25≤ BMI ≤ 29,99 kg/m²; BMI ≥ 30 kg/m²) Control group patients for psoriatic arthritis will be included during a rheumatologist consultation. They may have a non-inflammatory common disco-vertebral pathology (lumbago, lumbosciatic, spinal stenosis, neck pain, cervical arthritis and cervicobrachial neuralgia).
- Control group patients for psoriasis will be included during a dermatologist consultation. They may have a non-inflammatory skin disease (acne, acne rosacea, idiopathic Raynaud's phenomenon, basal cell carcinoma, acanthosis nigricans).
- In case of recruitment difficulties, healthy volunteers can be included.
- Postmenopausal women (for at least 24 months), surgically sterilized, or for women of childbearing age, efficacy use of contraceptive methods (contraceptive pills, injections or patches, intra-uterine device, double-barrier contraception),
- Signature of informed consent form
- French social security Affiliation
You may not qualify if:
- Pregnant woman
- Corticosteroid therapy \>10 mg of prednisone or equivalent /day
- Patients taking biological therapy (anti-TNFalpha therapy: infliximab, etanercept, adalimumab, golimumab, certolizumab ; anti-Interleukin-12/Interleukin-23: ustekinumab).
- Legal incapacity or limited legal capacity
- Presence of any condition hampering compliance with the study protocol, at the discretion of the investigator
- No french social security affiliation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chru Besancon
Besançon, 25030, France
Related Publications (1)
Toussirot E, Aubin F, Desmarets M, Wendling D, Auge B, Gillard J, Messica O, Guillot X, Laheurte C, Monnet E, Dumoulin G. Visceral adiposity in patients with psoriatic arthritis and psoriasis alone and its relationship with metabolic and cardiovascular risk. Rheumatology (Oxford). 2021 Jun 18;60(6):2816-2825. doi: 10.1093/rheumatology/keaa720.
PMID: 33232483DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
July 29, 2016
Study Start
April 1, 2014
Primary Completion
October 17, 2017
Study Completion
October 17, 2017
Last Updated
February 12, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share