Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513247
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Screening Program for Type 1 Diabetes in a High-Risk Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of a Pilot Screening Program for Type 1 Diabetes in a High-Risk Population
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type 1 diabetes mellitus T1D is a growing public health concern in Saudi Arabia ranking ninth globally in T1D incidence and tenth in T1D prevalence in children and the rates are expected to rise and incur greater healthcare costs Genetic and immunological factors are believed to play a significant role in disease development and recent clinical trials have shown promise in delaying or preventing T1D onset in high-risk individuals Early screening for immunological or genetic markers in children is crucial to identify high-risk individuals and provide early intervention Last year the American diabetes associations recommended clinicians to screen first degree relatives of individual with T1D Unfortunately Saudi Arabia and other Arab countries lack established T1D screening programs making early identification and intervention challenging The benefits of screening include education for symptom awareness monitoring to track progression to clinical T1D a five-fold reduction in diabetic ketoacidosis DKA at onset and improved glucose control for the first years following diagnosis To address this issue exploring effective and efficient screening methods in identifying high-risk children and the cultural acceptability feasibility and barriers to a broader implementation of such screening programs among Saudi families is crucial Therefore the investigators aim to conduct a prospective cohort study among young children and adolescents with a family history of T1D ie T1D first-degree relatives Children 2-18 years old will be screened using a 5 spots filter-dried blood sample for the following
1 Islet autoantibodies IAA GADA IA-2A Zn-transporter autoantibodies using the antibody detection by agglutination PCR ADAP assay
2 HLA phenotyping
3 Genetic risk score after the cross-sectional assessment those who are determined to be in stage I or II of T1D will be offered prospective follow-up for 5 years
1 Islet autoantibodies IAA GADA IA-2A Zn-transporter autoantibodies using the antibody detection by agglutination PCR ADAP assay
2 HLA phenotyping
3 Genetic risk score after the cross-sectional assessment those who are determined to be in stage I or II of T1D will be offered prospective follow-up for 5 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None