OHSU

IRB #

IRB00005023

Title

TrialNet Natural History Study of the Development of Type 1 Diabetes

Principal Investigator

Andrew Ahmann

Study Purpose

The goal of the Natural History Study is to learn more about how type 1 diabetes develops in 'at-risk' individuals. At risk individuals are those that have a blood relative with type 1 diabetes. Close relatives of people with type 1 diabetes are being studied in three steps (phases): Screening, Baseline Risk Assessment, and Follow-Up Risk Assessments.

Medical Condition(s)

Development of type 1 diabetes.

Eligibility Criteria

To participate in Phase 1 (Screening) of the Natural History Study, subjects must be:
- 1 to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes, OR
- 1 to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandparent with type 1 diabetes.

If you are found to have auto-antibodies in Phase 1 (Screening), you may be more likely to develop type 1 diabetes than other people and may be asked to participate in Phase 2 (Monitoring). Phase 2 (Monitoring) consists of semi-annual or annual study visits that include an Oral Glucose Tolerance Test, HbA1c, and autoantibody tests to confirm your risk for diabetes.

Age Range

1 - 45

Healthy Volunteers Needed

Yes

Duration of Participation

Phase 1 (Screening) requires 1-2 visits to the study site. Phase 2 (Monitoring) will require 1 study visit every six months for Semi-Annual Monitoring or 1 study visit once a year for Annual Monitoring for up to 5 years.

Minors Included

Yes

Contact

Bethany Wollam and Chris Bogan at 503-494-4704

Sponsor

NIH (NIDDK, NIAID, NICHD, NCRR), ADA, JDRF

Recruitment End

06/30/2015

Compensation Provided

Yes

Compensation

There is no compensation for phase 1 (Screening). During phase 2 (Monitoring), subjects will receive a small amount of money for each study visit.


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