HypothyroidismNCT03257566
Hypothyroidism in Patients With Type 1 Diabetes
An observational study of Hypothyroidism, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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 .
Who may be able to join
- Children with type 1 diabetes aging between 8 - 15 y .
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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 .
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 .
- Conditions
- Hypothyroidism
- Medical subject headings
- Hypothyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening the incidence of hypothyroidism in patients with type 1 diabetes
Measuring of thyroid stimulating hormone in patients with type 1 diabetes
Measured: after 1-2 years after diagnosis of Diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startNov 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Safwat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257566
- Sponsor's protocol ID
- rfihtptd
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Incidence of Hypothyroidism in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03257566
- Acronym / sponsor ID
- rfihtptd
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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 .
Key inclusion criteria (1 listed)
- Children with type 1 diabetes aging between 8 - 15 y .
Key exclusion criteria (7 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farouk Hassanen, MD (+201006178123, Dr.amir63@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening the incidence of hypothyroidism in patients with type 1 diabetes (time frame: after 1-2 years after diagnosis of Diabetes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.