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Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis (ADIPSO)

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ClinicalTrials.gov Identifier: NCT02849795
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Psoriasis Arthritic Psoriasis Other: bone densitometry Other: questionnaires Other: biological analyses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
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 : April 2014
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : October 17, 2017


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



Primary Outcome Measures :
  1. Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device) [ Time Frame: day 1 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849795


Locations
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France
Chru Besancon
Besancon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02849795     History of Changes
Other Study ID Numbers: ADIPSO
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Obesity, Abdominal
Adipokines
Risk of cardiovascular diseases
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Psoriasis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases