Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

Psoriasis Clinical Trial

— ADIPSO  

Official title:

Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis and Assessment of Their Relations With the Risk of Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849795
• Other study ID #: ADIPSO
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: February 9, 2018
• Start date: April 2014
• Est. completion date: October 17, 2017

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritic Psoriasis
• Arthritis, Psoriatic
• Cardiovascular Diseases
• Psoriasis

Intervention

Other:
• bone densitometry

• questionnaires

• biological analyses

Locations

Country	Name	City	State
France	Chru Besancon	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)		day 1
Secondary	Body fat		day 1
Secondary	body masses		day 1
Secondary	Intra-abdominal body fat mass (measured by CoreScan)		day 1
Secondary	Gynoid distribution of body fat		day 1
Secondary	SCORE (Systematic COronary Risk Evaluation).		day 1
Secondary	levels of adipokines		day 1
Secondary	Homeostasis model assessment of insulin resistance		day 1
Secondary	Bone mineral density of rachis, femoral neck, whole body		day 1
Secondary	levels of ghrelin		day 1