Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

Key facts

Study ID

NCT02580877

Run by

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

People needed

92

Starts

2016-01-01

Expected to finish

2018-03-01

Last updated by the study team

2020-07-27

Who can join

Age: 3 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
• Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
• Confirmed positive for insulin autoantibodies within previous six months
• Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months

You may not qualify if…

• Diagnosed with type 1 diabetes
• History of treatment with insulin or oral hypoglycemic agent
• History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
• Ongoing use of medications known to influence glucose tolerance
• Pregnant or intending to become pregnant while on study or lactating

Where it is running

• University of California - San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University-Riley Hospital for Children — Indianapolis, Indiana, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Columbia University-Naomi Berrie Diabetes Center — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• Walter and Eliza Hall Institute of Medical Research — Parkville, Victoria, Australia
• The Hospital for Sick Children — Toronto, Ontario, Canada
• San Raffaele Hospital — Milan, Italy

Full record on ClinicalTrials.gov

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