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Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Recruiting
I'm InterestedTrial ID: NCT02580877
Purpose
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).
Official Title
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Intervention(s):
drug: 67.5 mg oral insulin crystals daily
drug: 500mg oral insulin crystals every other week
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450