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Completed

NCT Number: NCT05596656

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

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Key information

Conditions

Diabetic Children

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Children Hospital

Al Mansurah, None Selected, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.