Hypothyroidism in Patients With Type 1 Diabetes

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03257566
Collaborator
(none)
300
22

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Risk Factors of Incidence of Hypothyroidism in Patients With Type 1 Diabetes
    Anticipated Study Start Date :
    Nov 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2019
    Anticipated Study Completion Date :
    Sep 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Screening the incidence of hypothyroidism in patients with type 1 diabetes [after 1-2 years after diagnosis of Diabetes]

      Measuring of thyroid stimulating hormone in patients with type 1 diabetes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Romany Safwat, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03257566
    Other Study ID Numbers:
    • rfihtptd
    First Posted:
    Aug 22, 2017
    Last Update Posted:
    Aug 22, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2017