IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study

NCT05596656 | Completed

• 1 other identifier: MS/17.07.21
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.

Conditions

Diabetic Children

Outcome Measures

Primary Outcomes (1)

• 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.

  20 minutes

Study Arms (2)

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

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.

Diagnostic Test: skin prick test

Interventions

skin prick test DIAGNOSTIC_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.

Non-allergic type 1 DM children; allergic type 1 DM children

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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%.

You may not qualify if:

• presence of other chronic disease associated with DM.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, None Selected, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 23369181 BACKGROUND

MeSH Terms

Interventions

Patch Tests

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Engy Osman, MD

  assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: February 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: December 25, 2019
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)