Natural History Study of the Development of Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
American Diabetes Association
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00097292
First received: November 19, 2004
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 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, 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 3 to 4 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.


Condition
Diabetes Mellitus, Type 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History Study of the Development of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Development of type 1 diabetes [ Time Frame: Monitoring is provided once or twice annually depending on risk level ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Metabolic and Autoantibody Assessments [ Designated as safety issue: No ]
    Oral Glucose Tolerance Test (OGTT) HbA1c Autoantibodies: ICA, IA-2A, GAD65A, mIAA, ZnT8A


Estimated Enrollment: 75000
Study Start Date: February 2004
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Annual Monitoring
Participants will be monitored annually for risk of type 1 diabetes.
Semi-annual Monitoring
Participants will be monitored every six months for risk of type 1 diabetes

Detailed Description:

The Natural History 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, IA-2A, mIAA). Islet cell autoantibodies (ICA) and ZnT8A are also measured in individuals positive for one or more biochemical autoantibodies. 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 initially and are confirmed by repeat testing, participants will be invited to have additional testing in baseline monitoring visit to determine their average risk of developing diabetes over the next 5 years. The baseline monitoring visit will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell autoantibodies if needed, measurement of HbA1c, and HLA (genetic) typing.

Individuals with less than 3% average risk will be asked to come for follow-up on annual basis; individuals with greater than average 32% risk 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.

  Eligibility

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

First and second/third degree relatives of individuals with type 1 diabetes.

Criteria

Inclusion Criteria:

  • Individuals 1 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  • Individuals 1-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097292

Contacts
Contact: TrialNet Central Information Center general info 1-800-425-8361

  Show 21 Study Locations
Sponsors and Collaborators
Juvenile Diabetes Research Foundation
American Diabetes Association
Investigators
Study Chair: Jay S Skyler, M.D. University of Miami
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00097292     History of Changes
Other Study ID Numbers: NHStudy (IND)
Study First Received: November 19, 2004
Last Updated: January 27, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
"at risk" for developing type 1 diabetes
T1DM
T1D
juvenile diabetes
Type 1 Diabetes TrialNet
TrialNet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014