NCT03257566

Brief Summary

Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset and in yearly intervals after the age of 12 yr. Furthermore, the International Society for Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more frequent if goitre present .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

August 15, 2017

Last Update Submit

August 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Screening the incidence of hypothyroidism in patients with type 1 diabetes

    Measuring of thyroid stimulating hormone in patients with type 1 diabetes

    after 1-2 years after diagnosis of Diabetes

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will be applied on children with type 1 diabetes attending Diabetes Clinic at Sidy Galal Health Assurance Clinic in Assuit , aging between 8 - 15 yrs .

You may qualify if:

  • \- Children with type 1 diabetes aging between 8 - 15 y .

You may not qualify if:

  • Cases with hyperthyroidism .
  • Areas known to have endemic goitre due to nutritional iodine deficiency .
  • History of maternal hypothyroidism and / or congenital hypothyroidism .
  • Children known to be normoglycaemic with already presented thyroid dysfunction .
  • Children with multiple endocrinopathies .
  • Children under treatment with drugs inducing hypothyroidism like amiodarone , lithium .
  • Children under treatment with drugs affecting insulin secretion like steroids , growth hormone therapy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Central Study Contacts

Farouk Hassanen, MD

CONTACT

Mohamed Amir, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 22, 2017

Study Start

November 1, 2017

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

August 22, 2017

Record last verified: 2017-08