DiabetesNCT02366273
Diabetes and Psoriasis
An observational study of Diabetes and Psoriasis, run by University of Pavia at 1 site in Italy.
Trial summary
Patients with psoriasis will be evaluated. The investigators will collect personal history, concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired fasting glucose and impaired glucose tollerance. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- PASI and HOMA index
- How many people
- 425 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2015to 30 Jun 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with psoriasis
Who may be able to join
- patients with psoriasis
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes and Psoriasis: Study on Prevalence, Role of Inflammation and Insulin-resistance
Patients with psoriasis will be evaluated. The investigators will collect personal history, concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if there is a correlation among inflammation, insulin-resistance and psoriasis.
- Being tested
- PASI and HOMA index
- Keywords
- Diabetes, Psoriasis, Inflammation, Insulin-resistance
- Medical subject headings
- Diabetes Mellitus, Psoriasis, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASI and HOMA indexOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of correlation between diabetes and psoriasis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion28 Feb 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, FESC, Principal investigator, University of Pavia - IRCCS Policlinico San Matteo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366273
- Sponsor's protocol ID
- P-20140023881
- Status last verified
- May 2022
- First submitted
- 11 Feb 2015
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and Psoriasis: Study on Prevalence, Role of Inflammation and Insulin-resistance
- ClinicalTrials.gov ID
- NCT02366273
- Acronym / sponsor ID
- P-20140023881
- Keywords
- Diabetes, Psoriasis, Inflammation, Insulin-resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Feb 2015 (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.
Patients with psoriasis will be evaluated. The investigators will collect personal history, concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if there is a correlation among inflammation, insulin-resistance and psoriasis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with psoriasis
Key inclusion criteria (1 listed)
- patients with psoriasis
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| PASI and HOMA index | Other | – |
Primary outcome
Evaluation of correlation between diabetes and psoriasis
Time frame: 3 years
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 24 May 2022.
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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.
Giuseppe Derosa, MD, PhD, FESC principal investigator
University of Pavia - IRCCS Policlinico San Matteo Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Psoriasis, run by University of Pavia at 1 site in Italy.
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 1 inclusion and 1 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 24 May 2022. 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 Italy. 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?
Evaluation of correlation between diabetes and psoriasis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.