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Summary

Eligibility
for people ages 8–35
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).

Details

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. This means that the immune system (the part of the body that helps fight infections) mistakenly attacks the cells that produce insulin (beta cells in the pancreas). As beta cells are destroyed by the immune cells, the ability to produce insulin is decreased and diabetes develops. Insulin helps keep blood glucose levels normal.

People with diabetes who have the ability to produce some of their own insulin (even though they still need to take insulin) may be able to achieve better glucose control than people who produce no insulin at all. Better glucose control has been shown to reduce the long-term complications of diabetes.

Several Immune Tolerance Network (ITN) drug treatment studies have been completed and have shown that some participants with new onset T1DM had partial disease remissions with therapy. Prior participants in these trials, had measured insulin secretion, at six month intervals, up to two years after diabetes diagnosis. It is unclear, however, if any of the interventions have produced a continuing disease remission in patients. For persons who have completed drug treatment trials, longer term follow-up is important for continued evaluation for effect of therapy on insulin production.

Keywords

Type 1 Diabetes Diabetes Mellitus Insulin Glucose Intolerance Prior ITN027AI Study Participants-NCT00129259 Prior ITN045AI Study Participants-NCT00965458

Eligibility

You can join if…

Open to people ages 8–35

  • Prior participation in protocol ITN027AI AbATE(NCT00129259) or protocol ITN045AI T1DAL(NCT00965458) studies
  • Ability to sign informed consent/assent (as applicable for children)

You CAN'T join if...

  • Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial.
  • Inability to comply with the study visit schedule and required assessments

Locations

  • Benaroya Research Institute accepting new patients
    Seattle, Washington, 98101, United States
  • Children's Mercy Hospital accepting new patients
    Kansas City, Missouri, 64108, United States
  • University of Iowa Health Care Division of Pediatric Endocrinology not yet accepting patients
    Iowa City, Iowa, 52242, United States
  • Indiana University Riley Hospital for Children accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Emory University not yet accepting patients
    Atlanta, Georgia, 30322, United States
  • Yale University accepting new patients
    New Haven, Connecticut, 06519, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
ITN T1D Extended Study (T1DES) website
ID
NCT02734277
Lead Scientist
Stephen Gitelman
Study Type
Observational
Last Updated
November 1, 2016
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