T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus

Completed

Conditions studied: Type 1 Diabetes Mellitus

In brief

Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas. Although it is known that T cells are important mediators of the disease, progress in the development of reliable T cell assays has been modest. The purpose of this study is to learn which T cell assays are most reliable and reproducible so that the investigators can improve their understanding about how type 1 diabetes occurs.

Key facts

Study ID

NCT00212329

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

100

Starts

2005-09-01

Expected to finish

2007-09-01

Last updated by the study team

2016-05-13

Who can join

Age: 8 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible, individuals with type 1 diabetes must be:
• Diagnosed with type 1 diabetes within one year of first study visit
• 8-35 years of age at time of first visit
• Weigh > 40 kg (88 lbs) at time of first visit
• Individuals who will serve as control subjects who do not have type 1 diabetes cannot have a first degree or second degree relative with type 1 diabetes.

You may not qualify if…

• Individuals must not:
• Have any major illness
• Be taking any steroid medications
• If female, should not be pregnant or breastfeeding.

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Naomi Berrie Diabetes Center, Columbia University — New York, New York, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Benaroya Research Institute at Virginia Mason — Seattle, Washington, United States
• University of Bristol — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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