Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097292
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2004-11-19
Brief Title:
TrialNet Pathway to Prevention of T1D
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
TrialNet Pathway to Prevention of T1D
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale
The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus T1DM Genetic and immunologic factors play a key role in the development of T1DM and characterization of the early metabolic abnormalities in T1DM is steadily increasing However information regarding the natural history of T1DM remains incomplete The TrialNet Natural History Study of the Development of T1DM Pathway to Prevention Study has been designed to clarify this picture and in so doing will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM
Purpose
TrialNet is an international network dedicated to the study prevention and early treatment of type 1 diabetes TrialNet sites are located throughout the United States Canada Finland United Kingdom Italy Germany Sweden Australia and New Zealand TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic immunologic and metabolic characteristics of individuals at risk for developing type 1 diabetes
The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease Relatives of people with type 1 diabetes have about a 5 percent chance of being positive for the antibodies associated with diabetes TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood A positive antibody test is an early indication that damage to insulin-secreting cells may have begun If this test is positive additional testing will be offered to determine the likelihood that a person may develop diabetes Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes
The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus T1DM Genetic and immunologic factors play a key role in the development of T1DM and characterization of the early metabolic abnormalities in T1DM is steadily increasing However information regarding the natural history of T1DM remains incomplete The TrialNet Natural History Study of the Development of T1DM Pathway to Prevention Study has been designed to clarify this picture and in so doing will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM
Purpose
TrialNet is an international network dedicated to the study prevention and early treatment of type 1 diabetes TrialNet sites are located throughout the United States Canada Finland United Kingdom Italy Germany Sweden Australia and New Zealand TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic immunologic and metabolic characteristics of individuals at risk for developing type 1 diabetes
The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease Relatives of people with type 1 diabetes have about a 5 percent chance of being positive for the antibodies associated with diabetes TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood A positive antibody test is an early indication that damage to insulin-secreting cells may have begun If this test is positive additional testing will be offered to determine the likelihood that a person may develop diabetes Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes
Detailed Description:
Detailed Description
The Pathway to Prevention Study is conducted in two parts
Screening
Monitoring annual and semi-annual depending on risk
In Screening a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies GAD and mIAA Additional autoantibodies ICA IA-2A and ZnT8A will also measured in individuals positive for mIAA ICA IA-2A and ZnT8A will be measured in individuals positive for GAD Participants can go to a TrialNet Clinical Center Affiliate or request a screening kit to have their blood drawn by a local physician or laboratory Participants will be provided with their screening results within 4-6 weeks
If autoantibodies are present participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test OGTT re-testing for biochemical and islet cell autoantibodies if needed and measurement of HbA1c
Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c 60 will be asked to come for follow-up on annual basis multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c 60will be asked to come for follow-up visits on semi-annual basis
Participants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such eg Oral Insulin prevention study or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study
The Pathway to Prevention Study is conducted in two parts
Screening
Monitoring annual and semi-annual depending on risk
In Screening a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies GAD and mIAA Additional autoantibodies ICA IA-2A and ZnT8A will also measured in individuals positive for mIAA ICA IA-2A and ZnT8A will be measured in individuals positive for GAD Participants can go to a TrialNet Clinical Center Affiliate or request a screening kit to have their blood drawn by a local physician or laboratory Participants will be provided with their screening results within 4-6 weeks
If autoantibodies are present participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test OGTT re-testing for biochemical and islet cell autoantibodies if needed and measurement of HbA1c
Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c 60 will be asked to come for follow-up on annual basis multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c 60will be asked to come for follow-up visits on semi-annual basis
Participants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such eg Oral Insulin prevention study or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UC4DK117009 | NIH | None | None |
| UC4DK106993 | NIH | None | httpsreporternihgovquickSearchUC4DK106993 |