Thyroid Function Among Pediatric Patients With DM

February 6, 2023 updated by: Mohamed Fathy Abd ELhay, Assiut University

Thyroid Function Among Pediatric Patients With Type 1 Diabetes Mellitus at Firs Presentation, From Patients' Characteristics to Disease Severity

Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence.

  • Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease.
  • In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the opportunity of developing DKA as the first manifestation of their disease.
  • In particular, autoimmune thyroiditis (AIT) is the most common disorder associated with type 1 Diabetes Mellitus.
  • AIT and type 1 Diabetes Mellitus have a common genetic background and similar pathogenesis; hence, they could occur in the same individual or family. The prevalence of thyroid autoantibodies in children with type1 Diabetes Mellitus ranges from 3% to 50% in different countries and populations, which is markedly higher than in the general population (range, 1% to 4%).
  • Besides thyroid autoantibodies can be detected at the initial diagnosis and after it.
  • Thyroiditis is often clinically silent but it may progress to autoimmune thyroid disease (AITD), recognized as overt or subclinical hypothyroidism or hyperthyroidism.
  • The American Diabetes Association (ADA) recommended screening Thyroid-Stimulating hormone after diagnosis of diabetes and then after every one to two years. It also recommended that patients found to have positive anti-Thyroid Peroxidase antibodies with normal thyroid function tests should be screened more frequently, every six months to a year .

Study Type

Observational

Enrollment (Anticipated)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence[1].

  • Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease[2].
  • In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the apportunity of developing DKA as the first manifestation of their disease. [3,4]

Description

Inclusion Criteria:

  • - patients between 2 year and <18 years of age in both sex
  • patients with T1DM that had not been on any thyroid medication

Exclusion Criteria:

  • - patients <2 years and >18 years of age in both sex
  • patient with systemic illnesses, diagnosed thyroid disorders and patients taking medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thyroid abnormalities among children and adolescents with type 1 diabetes mellitus when its first detected and its relationship with disease-related variables.
Time Frame: Baseline
The aim of this study was to detect the prevalence of thyroid functions TSH,T3,T4 abnormalities and the relationship of positive anti-thyroid antibodies to potential risk factors, including, age, gender, duration of diabetes among children and adolescents with type 1 diabetes mellitus when its first detected
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

March 30, 2024

Study Completion (ANTICIPATED)

March 30, 2024

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

February 6, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thyroid function in DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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