ADIPSO: Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02849795

Collaborator

(none)

199

Enrollment

Location

Arm

42.5

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Arthritic Psoriasis	Other: bone densitometry Other: questionnaires Other: biological analyses	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Oct 17, 2017

Actual Study Completion Date :

Oct 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psoriasis and arthritic psoriasis additional blood sample for biological analyses bone densitometry questionnaires	Other: bone densitometry Other: questionnaires Other: biological analyses

Arm

Intervention/Treatment

Experimental: Psoriasis and arthritic psoriasis

additional blood sample for biological analyses bone densitometry questionnaires

Other: bone densitometry

Other: questionnaires

Other: biological analyses

Outcome Measures

Primary Outcome Measures

Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device) [day 1]

Secondary Outcome Measures

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]
levels of adipokines [day 1]
Homeostasis model assessment of insulin resistance [day 1]
Bone mineral density of rachis, femoral neck, whole body [day 1]
levels of ghrelin [day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chru Besancon	Besancon		France	25030

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02849795

Other Study ID Numbers:

ADIPSO

First Posted:

Jul 29, 2016

Last Update Posted:

Feb 12, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Obesity, Abdominal

Adipokines

Risk of cardiovascular diseases

Additional relevant MeSH terms:

Arthritis, Psoriatic

Psoriasis

Study Results

No Results Posted as of Feb 12, 2018