Thyroid Function in DMNCT05717933
Thyroid Function Among Pediatric Patients With DM
An observational study of Thyroid Function in DM, run by Assiut University.
Trial summary
Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Thyroid Function in DM
- What is being tested?
- thyroid hormones
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 30 Mar 2024
- 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 2 to 18 years
- All sexes
- Child, Adult
Study population: Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence[1]. * Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease[2]. * In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the apportunity of developing DKA as the first manifestation of their disease. [3,4]
Who may be able to join
- - patients between 2 year and <18 years of age in both sex
- patients with T1DM that had not been on any thyroid medication
Who cannot join
- - patients <2 years and >18 years of age in both sex
- patient with systemic illnesses, diagnosed thyroid disorders and patients taking medications
About this study
Official title: Thyroid Function Among Pediatric Patients With Type 1 Diabetes Mellitus at Firs Presentation, From Patients' Characteristics to Disease Severity
Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity
Read the detailed description
Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence.
- Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease.
- In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the opportunity of developing DKA as the first manifestation of their disease.
- In particular, autoimmune thyroiditis (AIT) is the most common disorder associated with type 1 Diabetes Mellitus.
- AIT and type 1 Diabetes Mellitus have a common genetic background and similar pathogenesis; hence, they could occur in the same individual or family. The prevalence of thyroid autoantibodies in children with type1 Diabetes Mellitus ranges from 3% to 50% in different countries and populations, which is markedly higher than in the general population (range, 1% to 4%).
- Besides thyroid autoantibodies can be detected at the initial diagnosis and after it.
- Thyroiditis is often clinically silent but it may progress to autoimmune thyroid disease (AITD), recognized as overt or subclinical hypothyroidism or hyperthyroidism.
- The American Diabetes Association (ADA) recommended screening Thyroid-Stimulating hormone after diagnosis of diabetes and then after every one to two years. It also recommended that patients found to have positive anti-Thyroid Peroxidase antibodies with normal thyroid function tests should be screened more frequently, every six months to a year .
- Conditions
- Thyroid Function in DM
- Being tested
- thyroid hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid hormonesDiagnostic test
Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid abnormalities among children and adolescents with type 1 diabetes mellitus when its first detected and its relationship with disease-related variables.
The aim of this study was to detect the prevalence of thyroid functions TSH,T3,T4 abnormalities and the relationship of positive anti-thyroid antibodies to potential risk factors, including, age, gender, duration of diabetes among children and adolescents with type 1 diabetes mellitus when its first detected
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Function in DMStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy Abd ELhay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717933
- Sponsor's protocol ID
- thyroid function in DM
- Status last verified
- Feb 2023
- First submitted
- 1 Sep 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Metwalley KA, El-Saied AR. Thyroid abnormalities in Egyptian children and adolescents with type 1 diabetes mellitus: A single center study from Upper Egypt. Indian J Endocrinol Metab. 2014 Sep;18(5):637-41. doi: 10.4103/2230-8210.139218.
PubMed 25285279
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function Among Pediatric Patients With Type 1 Diabetes Mellitus at Firs Presentation, From Patients' Characteristics to Disease Severity
- ClinicalTrials.gov ID
- NCT05717933
- Acronym / sponsor ID
- thyroid function in DM
- Conditions
- Thyroid Function in DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity
Detailed description
Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence.
- Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease.
- In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the opportunity of developing DKA as the first manifestation of their disease.
- In particular, autoimmune thyroiditis (AIT) is the most common disorder associated with type 1 Diabetes Mellitus.
- AIT and type 1 Diabetes Mellitus have a common genetic background and similar pathogenesis; hence, they could occur in the same individual or family. The prevalence of thyroid autoantibodies in children with type1 Diabetes Mellitus ranges from 3% to 50% in different countries and populations, which is markedly higher than in the general population (range, 1% to 4%).
- Besides thyroid autoantibodies can be detected at the initial diagnosis and after it.
- Thyroiditis is often clinically silent but it may progress to autoimmune thyroid disease (AITD), recognized as overt or subclinical hypothyroidism or hyperthyroidism.
- The American Diabetes Association (ADA) recommended screening Thyroid-Stimulating hormone after diagnosis of diabetes and then after every one to two years. It also recommended that patients found to have positive anti-Thyroid Peroxidase antibodies with normal thyroid function tests should be screened more frequently, every six months to a year .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence[1]. * Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease[2]. * In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the apportunity of developing DKA as the first manifestation of their disease. [3,4]
Key inclusion criteria (2 listed)
- - patients between 2 year and <18 years of age in both sex
- patients with T1DM that had not been on any thyroid medication
Key exclusion criteria (2 listed)
- - patients <2 years and >18 years of age in both sex
- patient with systemic illnesses, diagnosed thyroid disorders and patients taking medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroid hormonesThyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity | Diagnostic test | – |
Primary outcome
thyroid abnormalities among children and adolescents with type 1 diabetes mellitus when its first detected and its relationship with disease-related variables.
Time frame: Baseline
The aim of this study was to detect the prevalence of thyroid functions TSH,T3,T4 abnormalities and the relationship of positive anti-thyroid antibodies to potential risk factors, including, age, gender, duration of diabetes among children and adolescents with type 1 diabetes mellitus when its first detected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 25285279Metwalley KA, El-Saied AR. Thyroid abnormalities in Egyptian children and adolescents with type 1 diabetes mellitus: A single center study from Upper Egypt. Indian J Endocrinol Metab. 2014 Sep;18(5):637-41. doi: 10.4103/2230-8210.139218.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Function in DM, 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 2 inclusion and 2 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 8 Feb 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid abnormalities among children and adolescents with type 1 diabetes mellitus when its first detected and its relationship with disease-related variables. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717933, which also lists 1 linked publication.
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 8 Feb 2023.