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

Completed

• Conditions: Diabetic Children
• Interventions: Diagnostic Test: skin prick test

• Registration Number: NCT05596656
• Lead Sponsor: Mansoura University Children Hospital

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-12-25
• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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%.

Exclusion Criteria

• presence of other chronic disease associated with DM.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
allergic type 1 DM children	skin prick test	45 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	skin prick test	Forty-five Non-allergic type 1 DM children were selected as age and sex matched control group.

Primary Outcome Measures

Name	Time	Method
positive skin prick test	20 minutes	a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansoura, None Selected, Egypt