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

February 9, 2018 updated by: Centre Hospitalier Universitaire de Besançon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • CHRU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Body fat
Time Frame: day 1
day 1
body masses
Time Frame: day 1
day 1
Intra-abdominal body fat mass (measured by CoreScan)
Time Frame: day 1
day 1
Gynoid distribution of body fat
Time Frame: day 1
day 1
SCORE (Systematic COronary Risk Evaluation).
Time Frame: day 1
day 1
levels of adipokines
Time Frame: day 1
day 1
Homeostasis model assessment of insulin resistance
Time Frame: day 1
day 1
Bone mineral density of rachis, femoral neck, whole body
Time Frame: day 1
day 1
levels of ghrelin
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 17, 2017

Study Completion (Actual)

October 17, 2017

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADIPSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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