CClinicalTrials.gg
Status unknownNCT03257566Updated Aug 22, 2017

Hypothyroidism in Patients With Type 1 Diabetes

An observational study in Hypothyroidism, sponsored by Assiut University. Status unknown. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
8 Years to 15 Years
Sex
All
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Hypothyroidism

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03

Who can participate

Ages eligible
8 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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 .

Inclusion criteria

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

Exclusion criteria

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 .
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

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

    Time frame: after 1-2 years after diagnosis of Diabetes

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257566
Lead sponsor
Assiut University
Responsible party
Romany Safwat (principal investigator, Assiut University) — Principal investigator
First posted
Aug 22, 2017
Start date
Nov 2017 (estimated)
Primary completion
Jul 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Aug 22, 2017

Study contacts

Farouk Hassanen, MD
Contact
Dr.amir63@yahoo.com
+201006178123
Mohamed Amir, MD
Contact
Dr.amir63@yahoo.com
+201005689353

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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