Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Trial ID or NCT#
NCT02580877
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 3 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Darrell Wilson
Contact us to find out if this trial is right for you.
Contact
Trudy Esrey
650-498-4450
View on ClinicalTrials.gov
