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Pathway to Prevention Study

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ClinicalTrials.gov Identifier: NCT00097292
Recruitment Status : Recruiting
First Posted : November 22, 2004
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation
American Diabetes Association
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date November 19, 2004
First Posted Date November 22, 2004
Last Update Posted Date July 17, 2019
Study Start Date February 2004
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2013)
Development of type 1 diabetes [ Time Frame: Monitoring is provided once or twice annually depending on risk level ]
The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00097292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 13, 2019)
Metabolic and Autoantibody Assessments [ Time Frame: Metabolic and Autoantibody assessments are provided once or twice annually depending on risk level ]
Oral Glucose Tolerance Test (OGTT) HbA1c Autoantibodies: ICA, IA-2A, GAD65A, mIAA, ZnT8A
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pathway to Prevention Study
Official Title Natural History Study of the Development of Type 1 Diabetes
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.

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 < 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will 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 (e.g., 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population First and second/third degree relatives of individuals with type 1 diabetes.
Condition Diabetes Mellitus, Type 1
Intervention Not Provided
Study Groups/Cohorts
  • Annual Re-Testing/Annual Metabolic Monitoring
    Participants will be monitored annually for risk of type 1 diabetes.
  • Semi-Annual Metabolic Monitoring
    Participants will be monitored every six months for risk of type 1 diabetes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2005)
75000
Original Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  • Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
  • Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.

Exclusion Criteria:

To be eligible a person must not:

  • Have diabetes already
  • Have a previous history of being treated with insulin or oral diabetes medications.
  • Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
  • Have any known serious diseases
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Months to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: TrialNet Central Information Center general info 1-800-425-8361
Listed Location Countries Australia,   Canada,   Finland,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00097292
Other Study ID Numbers NHStudy (IND)
UC4DK117009 ( U.S. NIH Grant/Contract )
UC4DK106993 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Center for Research Resources (NCRR)
  • Juvenile Diabetes Research Foundation
  • American Diabetes Association
Investigators
Study Chair: Carla J Greenbaum, M.D. Benaroya Research Institute
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date May 2019