Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Arthritic Psoriasis; Psoriasis
• Interventions: Other: bone densitometry; Other: questionnaires; Other: biological analyses

• Registration Number: NCT02849795
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-29
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psoriasis and arthritic psoriasis	questionnaires	additional blood sample for biological analyses bone densitometry questionnaires
Psoriasis and arthritic psoriasis	bone densitometry	additional blood sample for biological analyses bone densitometry questionnaires
Psoriasis and arthritic psoriasis	biological analyses	additional blood sample for biological analyses bone densitometry questionnaires

Primary Outcome Measures

Name	Time	Method
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)	day 1

Secondary Outcome Measures

Name	Time	Method
Body fat	day 1
body masses	day 1
Homeostasis model assessment of insulin resistance	day 1
Intra-abdominal body fat mass (measured by CoreScan)	day 1
SCORE (Systematic COronary Risk Evaluation).	day 1
levels of adipokines	day 1
levels of ghrelin	day 1
Gynoid distribution of body fat	day 1
Bone mineral density of rachis, femoral neck, whole body	day 1

Trial Locations

Locations (1)

Chru Besancon; 🇫🇷 Besancon, France