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CompletedNCT02849795ADIPSOUpdated Feb 12, 2018

Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

An interventional study of bone densitometry and questionnaires in Psoriasis and Arthritic Psoriasis, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-12.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
199
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Arthritic Psoriasis

Keywords

  • Obesity, Abdominal
  • Adipokines
  • Risk of cardiovascular diseases
03

In context

Arthritis, Psoriatic

579 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's enrollment of 199 is above the median of 135 across 322 interventional studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
199 participants (actual)

Study arms

  • Experimental
    Psoriasis and arthritic psoriasis

    additional blood sample for biological analyses bone densitometry questionnaires

    Other: bone densitometry · Other: questionnaires · Other: biological analyses

Interventions

  • Otherbone densitometry
  • Otherquestionnaires
  • Otherbiological analyses
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What researchers measure

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

07

Study locations

1 site
  • Chru Besancon
    Besancon, 25030, France
08

References and documents

Publications

  • 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. PubMed 33232483 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02849795
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Apr 2014
Primary completion
Oct 17, 2017
Completion
Oct 17, 2017
Last update
Feb 12, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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