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Completed

NCT Number: NCT02849795

Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bone densitometry

Other

questionnaires

Other

biological analyses

Other

Primary outcomes

  1. Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)

    Time frame: day 1

Secondary outcomes

  1. Body fat

    Time frame: day 1

  2. body masses

    Time frame: day 1

  3. Intra-abdominal body fat mass (measured by CoreScan)

    Time frame: day 1

  4. Gynoid distribution of body fat

    Time frame: day 1

  5. SCORE (Systematic COronary Risk Evaluation).

    Time frame: day 1

  6. levels of adipokines

    Time frame: day 1

  7. Homeostasis model assessment of insulin resistance

    Time frame: day 1

  8. Bone mineral density of rachis, femoral neck, whole body

    Time frame: day 1

  9. levels of ghrelin

    Time frame: day 1

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: ADIPSO

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2016
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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