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

Primary Purpose

Psoriasis, Arthritic Psoriasis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bone densitometry
questionnaires
biological analyses
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring Obesity, Abdominal, Adipokines, Risk of cardiovascular diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chru Besancon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psoriasis and arthritic psoriasis

Arm Description

additional blood sample for biological analyses bone densitometry questionnaires

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2016
Last Updated
February 9, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02849795
Brief Title
Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 17, 2017 (Actual)
Study Completion Date
October 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Arthritic Psoriasis
Keywords
Obesity, Abdominal, Adipokines, Risk of cardiovascular diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psoriasis and arthritic psoriasis
Arm Type
Experimental
Arm Description
additional blood sample for biological analyses bone densitometry questionnaires
Intervention Type
Other
Intervention Name(s)
bone densitometry
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Type
Other
Intervention Name(s)
biological analyses
Primary Outcome Measure Information:
Title
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Body fat
Time Frame
day 1
Title
body masses
Time Frame
day 1
Title
Intra-abdominal body fat mass (measured by CoreScan)
Time Frame
day 1
Title
Gynoid distribution of body fat
Time Frame
day 1
Title
SCORE (Systematic COronary Risk Evaluation).
Time Frame
day 1
Title
levels of adipokines
Time Frame
day 1
Title
Homeostasis model assessment of insulin resistance
Time Frame
day 1
Title
Bone mineral density of rachis, femoral neck, whole body
Time Frame
day 1
Title
levels of ghrelin
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Chru Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33232483
Citation
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.
Results Reference
derived

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Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

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