Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

NCT ID: NCT02849795

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-10-17

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Arthritic Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Psoriasis and arthritic psoriasis

additional blood sample for biological analyses bone densitometry questionnaires

Group Type EXPERIMENTAL

bone densitometry

Intervention Type OTHER

questionnaires

Intervention Type OTHER

biological analyses

Intervention Type OTHER

Interventions

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bone densitometry

Intervention Type OTHER

questionnaires

Intervention Type OTHER

biological analyses

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chru Besancon

Besançon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33232483 (View on PubMed)

Other Identifiers

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ADIPSO

Identifier Type: -

Identifier Source: org_study_id

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