PsoriasisADIPSONCT02849795
Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis
A study testing bone densitometry, questionnaires and biological analyses in people with Psoriasis and Arthritic Psoriasis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Arthritic Psoriasis
- What is being tested?
- bone densitometry, questionnaires and biological analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to 17 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Psoriasis, Arthritic Psoriasis
- Being tested
- bone densitometry, questionnaires, biological analyses
- Keywords
- Obesity, Abdominal, Adipokines, Risk of cardiovascular diseases
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone densitometryOther
questionnairesOther
biological analysesOther
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis and arthritic psoriasis | Experimental | additional blood sample for biological analyses bone densitometry questionnaires Receives: Other: bone densitometry; Other: questionnaires; Other: biological analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
Measured: day 1
Secondary outcomes (9)
Body fat
Measured: day 1
body masses
Measured: day 1
Intra-abdominal body fat mass (measured by CoreScan)
Measured: day 1
Gynoid distribution of body fat
Measured: day 1
SCORE (Systematic COronary Risk Evaluation).
Measured: day 1
levels of adipokines
Measured: day 1
Homeostasis model assessment of insulin resistance
Measured: day 1
Bone mineral density of rachis, femoral neck, whole body
Measured: day 1
levels of ghrelin
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startApr 2014
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849795
- Sponsor's protocol ID
- ADIPSO
- Acronym
- ADIPSO
- Status last verified
- Feb 2018
- First submitted
- 27 Jul 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis and Assessment of Their Relations With the Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02849795
- Acronym / sponsor ID
- ADIPSO / ADIPSO
- Conditions
- Psoriasis, Arthritic Psoriasis
- Keywords
- Obesity, Abdominal, Adipokines, Risk of cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis and arthritic psoriasis | Experimental | Other: bone densitometry, Other: questionnaires, Other: biological analysesadditional blood sample for biological analyses bone densitometry questionnaires |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone densitometry | Other | Psoriasis and arthritic psoriasis |
| questionnaires | Other | Psoriasis and arthritic psoriasis |
| biological analyses | Other | Psoriasis and arthritic psoriasis |
Primary outcome
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
Time frame: day 1
9 secondary outcomes
Body fat
Time frame: day 1
body masses
Time frame: day 1
Intra-abdominal body fat mass (measured by CoreScan)
Time frame: day 1
Gynoid distribution of body fat
Time frame: day 1
SCORE (Systematic COronary Risk Evaluation).
Time frame: day 1
levels of adipokines
Time frame: day 1
Homeostasis model assessment of insulin resistance
Time frame: day 1
Bone mineral density of rachis, femoral neck, whole body
Time frame: day 1
levels of ghrelin
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 33232483Toussirot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone densitometry, questionnaires and biological analyses in people with Psoriasis and Arthritic Psoriasis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.