Atopic DermatitisNCT05904509
Insulin Resistance in Atopic Dermatitis Patients
An observational study of Atopic Dermatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Oct 2023
- 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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Atopic dermatitis patients confirmed by a dermatologist
Who may be able to join
- Atopic dermatitis patients confirmed by a dermatologist
Who cannot join
- patients younger than 2 years
- patients older than 80 years
- Atopic dermatitis patients without HOMA-IR result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Insulin Resistance and Disease Severity and Duration in Atopic Dermatitis Patients
The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis.
Read the detailed description
The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis. EASI and SCORAD values and disease duration of atopic dermatitis patients are calculated during the examination. HOMA-IR blood test result is compared with the results.
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, insulin resistance
- Medical subject headings
- Dermatitis, Atopic, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR
Patients' blood test show the result of fasting insulin (microU/L) x fasting glucose (mmol/L)/22.5
Measured: 12 months
SCORAD index
Severity scoring of atopic dermatitis is calculated for each patient in the study. 6 intensity items (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness); 2 subjective symptoms(itch, sleeplessness); body surface area are studied. Max score is 103.
Measured: 12 months
EASI index
Eczema Area and Severity Index is calculated for each patient in the study. Body surface area, 4 intensity items(erythema, induration, excoriation, lichenification) are studied. Max score is 72.
Measured: 12 months
Duration of the disease
The time from the first onset of symptoms of the disease to the present. The relationship between insulin resistance and disease duration is examined
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Sep 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904509
- Sponsor's protocol ID
- E-54022451-050.05.04-56968
- Status last verified
- Feb 2024
- First submitted
- 6 Jun 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Insulin Resistance and Disease Severity and Duration in Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT05904509
- Acronym / sponsor ID
- E-54022451-050.05.04-56968
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- 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.
The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis.
Detailed description
The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis. EASI and SCORAD values and disease duration of atopic dermatitis patients are calculated during the examination. HOMA-IR blood test result is compared with the results.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Atopic dermatitis patients confirmed by a dermatologist
Key inclusion criteria (1 listed)
- Atopic dermatitis patients confirmed by a dermatologist
Key exclusion criteria (3 listed)
- patients younger than 2 years
- patients older than 80 years
- Atopic dermatitis patients without HOMA-IR result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HOMA-IR
Time frame: 12 months
Patients' blood test show the result of fasting insulin (microU/L) x fasting glucose (mmol/L)/22.5
SCORAD index
Time frame: 12 months
Severity scoring of atopic dermatitis is calculated for each patient in the study. 6 intensity items (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness); 2 subjective symptoms(itch, sleeplessness); body surface area are studied. Max score is 103.
EASI index
Time frame: 12 months
Eczema Area and Severity Index is calculated for each patient in the study. Body surface area, 4 intensity items(erythema, induration, excoriation, lichenification) are studied. Max score is 72.
Duration of the disease
Time frame: 12 months
The time from the first onset of symptoms of the disease to the present. The relationship between insulin resistance and disease duration is examined
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 13 Feb 2024.
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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?
An observational study of Atopic Dermatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 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 13 Feb 2024. 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 Turkey (Türkiye). 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?
HOMA-IR (time frame: 12 months). The study lists 4 primary outcomes in all. 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 13 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.