Recruiting

Natural History StudyTrialNet Pathway to Prevention of T1D

Sponsor:

University of South Florida

Code:

NCT00097292

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 2 - 45

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT00097292

Start date

Feb 1, 2004

Status verified date

Jun, 2025

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies

Exclusion Criteria:

To be eligible a person must not:

Have diabetes already
Have previous or current use of medications for the control of hyperglycemia/diabetes.
Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)
Have known severe active diseases, and/or diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study

Study Design

Enrollment

75000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

Development of type 1 diabetes [ Time Frame: Monitoring is provided once or twice annually depending on risk level ]

Central Contacts and Locations

Central contacts

TrialNet Central Information Center general info

1-800-425-8361

Locations

Childrens Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Marissa Erickson

714-509-8613 merickson@choc.org

Principal Investigator:

Mark Daniels, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143-0434

Contacts

Karen Ko

844-813-8273 clinicalresearch@diabetes.ucsf.edu

Principal Investigator:

Stephen Gitelman, MD

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305-5208

Contacts

Trudy Esrey, RD

650-498-4450 tesrey@stanford.edu

Principal Investigator:

Darrell Wilson, MD

Barbara Davis Center for Childhood Diabetes

Recruiting

Denver, Colorado, United States, 80262

Contacts

Brenda Bradfield

303-724-8595 brenda.bradfield@CUANSCHUTZ.EDU

Principal Investigator:

Andrea Steck, MD

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Lori Carria

203-737-3595 lori.carria@yale.edu

Principal Investigator:

Jennifer Sherr, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32601-0296

Contacts

Jennifer Hosford

352-294-5759 jennifer.hosford@peds.ufl.edu

Principal Investigator:

Michael Haller, MD

Emory Children's Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Xiaomiao Lan-Pidhainy, RN

404-712-0051 xlanpid@emory.edu

Principal Investigator:

Andrew Muir, MD

Riley Hospital for Children, Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maria Spall

866-230-8486 malnicho@iu.edu

Principal Investigator:

Linda DeMeglio, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nora Bryant

617-309-4141 nora.bryant@joslin.harvard.edu

Principal Investigator:

Jason Gaglia, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 58944

Contacts

Beth Pappenfus

612-624-2922 papp0086@umn.edu

Principal Investigator:

Antoinette Moran, MD

The Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Cassandra McClain

816-960-8877 clmcclain@cmh.edu

Principal Investigator:

Wayne Moore, Md, PhD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Jamie R Hyatt

212-851-5425 jh4470@cumc.columbia.edu

Principal Investigator:

Robin S Goland, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kelli DeLallo, RN

412-692-5210 kelli.delallo@chp.edu

Principal Investigator:

Dorothy Becker, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Faith Brendle, RN

615-936-8638 faith.brendle@vanderbilt.edu

Principal Investigator:

William Russell, MD

University of Texas Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75390-8858

Contacts

Lindsay Harter

214-648-4725 Lindsay.Harter@UTSouthwestern.edu

Principal Investigator:

Perrin White, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Sandra Pena

832-822-3380 sypena@texaschildrens.org

Principal Investigator:

Maria Redondo, MD

Benaroya Research Institute

Recruiting

Seattle, Washington, United States, 98101-2795

Contacts

Katie Bennett

206-341-8945 diabetes@benaroyaresearch.org

Principal Investigator:

Carla Greenbaum, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G-1x8

Contacts

Rebecca Stochinsky

(416) 813-7654 rebecca.stochinsky@sickkids.ca

Principal Investigator:

Diane Wherrett, MD

More Information

Sponsor

University of South Florida

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Keywords

"at risk" for developing type 1 diabetes
T1DM
T1D
juvenile diabetes
Type 1 Diabetes TrialNet
TrialNet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-07-01.