Diabetic ChildrenNCT05596656
IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study
An observational study of Diabetic Children, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Diabetic Children
- What is being tested?
- skin prick test
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 25 Dec 2019
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with at least 2 years' duration of Type 1 Diabetes Mellitus. Participants: among 200 cases with Type 1 DM children following up at endocrinology unit
Who may be able to join
- Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:
- Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).
- Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.
- Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).
- HbA1c ≥6.5%.
Who cannot join
- presence of other chronic disease associated with DM.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Children Hospital
Al Mansurah, None Selected, 35516
About this study
an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.
- Conditions
- Diabetic Children
- Being tested
- skin prick test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin prick testDiagnostic test
Skin prick testing was performed to all diabetic child with history of allergy. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 - 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.
The location of each allergen was marked with a pen on the volar aspect of forearm to properly identify test results, at least 2 cm from the wrist and the antecubital fossae. The distance between two skin prick tests should be appropriate to avoid false-positive reactions due to direct contamination of a nearby test. A drop of each test solution should be placed on the skin in identical order for each subject tested and immediately pricked with a single-head metal lancet.
| Study group | Role | What they receive |
|---|---|---|
| allergic type 1 DM children | 45 cases were considered allergic based on written questionnaire taken by the resident. Diagnosis of atopy was confirmed by skin prick testing Receives: Diagnostic Test: skin prick test | |
| Non-allergic type 1 DM children | Forty-five Non-allergic type 1 DM children were selected as age and sex matched control group. Receives: Diagnostic Test: skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive skin prick test
a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion25 Dec 2019
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 Diabetic ChildrenStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Osman Ahmed, Mansoura University Children Hospital
- Investigators
- Engy Osman, MD, Study director, assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596656
- Sponsor's protocol ID
- MS/17.07.21
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Individual data sharing
- No
Publications
Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
PubMed 23369181
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study
- ClinicalTrials.gov ID
- NCT05596656
- Acronym / sponsor ID
- MS/17.07.21
- Conditions
- Diabetic Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 27 Oct 2022 (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.
an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allergic type 1 DM children | – | Diagnostic Test: skin prick test45 cases were considered allergic based on written questionnaire taken by the resident. Diagnosis of atopy was confirmed by skin prick testing |
| Non-allergic type 1 DM children | – | Diagnostic Test: skin prick testForty-five Non-allergic type 1 DM children were selected as age and sex matched control group. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with at least 2 years' duration of Type 1 Diabetes Mellitus. Participants: among 200 cases with Type 1 DM children following up at endocrinology unit
Key inclusion criteria (5 listed)
- Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:
- Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).
- Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.
- Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).
- HbA1c ≥6.5%.
Key exclusion criteria (1 listed)
- presence of other chronic disease associated with DM.
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 |
|---|---|---|
| skin prick testSkin prick testing was performed to all diabetic child with history of allergy. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 - 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens. The location of each allergen was marked with a pen on the volar aspect of forearm to properly identify test results, at least 2 cm from the wrist and the antecubital fossae. The distance between two skin prick tests should be appropriate to avoid false-positive reactions due to direct contamination of a nearby test. A drop of each test solution should be placed on the skin in identical order for each subject tested and immediately pricked with a single-head metal lancet. | Diagnostic test | Non-allergic type 1 DM children, allergic type 1 DM children |
Primary outcome
positive skin prick test
Time frame: 20 minutes
a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.
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 28 Oct 2022.
- Background: PubMed 23369181Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
- 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.
Engy Osman, MD study director
assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.
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 Diabetic Children, run by Mansoura University Children Hospital at 1 site in Egypt.
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 5 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 28 Oct 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 Egypt. 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?
positive skin prick test (time frame: 20 minutes). 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 NCT05596656, 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 28 Oct 2022.