Clinical trial NCT02849795: Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis
Official title: Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis and Assessment of Their Relations With the Risk of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Arthritic Psoriasis
Keywords: Obesity, Abdominal
Adipokines
Risk of cardiovascular diseases
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
timeFrame: day 1
Secondary outcomes:
measure: Body fat
timeFrame: day 1
measure: body masses
timeFrame: day 1
measure: Intra-abdominal body fat mass (measured by CoreScan)
timeFrame: day 1
measure: Gynoid distribution of body fat
timeFrame: day 1
measure: SCORE (Systematic COronary Risk Evaluation).
timeFrame: day 1
measure: levels of adipokines
timeFrame: day 1
measure: Homeostasis model assessment of insulin resistance
timeFrame: day 1
measure: Bone mineral density of rachis, femoral neck, whole body
timeFrame: day 1
measure: levels of ghrelin
timeFrame: day 1
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chru Besancon
Study officials:
References:
citation: 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.