Hypothyroidism in Patients With Type 1 Diabetes

August 18, 2017 updated by: Romany Safwat, Assiut University

Risk Factors of Incidence of Hypothyroidism in Patients With Type 1 Diabetes

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 .

Study Overview

Status

Unknown

Conditions

Detailed Description

Type 1 diabetes is an organ-specific autoimmune disease characterized by the selective destruction of pancreatic β-cells. The histopathology of type 1 diabetes is defined by a decreased β-cell mass infiltration of mononuclear cells into the islets of Langerhans , this lesion was later called 'insulitis', and it is the hallmark of the disease .

Insulitis was observed in 70% of patients with acute onset type 1 diabetes and concluded that this disease was caused by a β-cell-specific autoimmune process .

Furthermore, in a study demonstrated cellular autoimmunity in patients with type 1 diabetes using the leukocyte migration test and speculated that cellular hypersensitivity was the counter part of lymphocytic infiltration in islets . Therefore, it is speculated that cell-mediated immunity could play an important part in the pathogenesis of type 1 diabetes .

As a view suggesting that type 1 diabetes is an autoimmune disease, there is some evidence that type 1 diabetes is often complicated with other autoimmune diseases or that anti-islet antibodies precede the clinical onset of the disease.

So, it is found that type 1 diabetes is frequently associated with other organ-specific autoimmune diseases, including hypothyroidism , pernicious anaemia, and idiopathic Addison's disease .The most common coexisting organ autoimmune disease is hypothyroidism (>90%), the prevalence of anti-thyroid autoantibodies in children with type 1 diabetes at disease onset is about 20% .

It is generally accepted that is a T cell-mediated autoimmune disease and that circulating autoantibodies to various islet cell antigens are induced following the destruction of pancreatic β cells .

Furthermore, it is reported that the prevalence of anti-thyroid antibodies increases with increasing age and that the presence of anti-thyroid antibodies at diagnosis of type 1 diabetes predicts the development of future thyroid disease as patients with antithyroid antibodies are 18 times more likely to develop thyroid disease than patients without anti-thyroid antibodies .

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 .

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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 .

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Screening the incidence of hypothyroidism in patients with type 1 diabetes
Time Frame: after 1-2 years after diagnosis of Diabetes
Measuring of thyroid stimulating hormone in patients with type 1 diabetes
after 1-2 years after diagnosis of Diabetes

Collaborators and Investigators

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

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)

November 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • rfihtptd

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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