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

Not Recruiting

Trial ID: NCT02580877

Age - 3 Years-45 Years Gender - ALL Accepting Healthy Volunteers - No

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)

Darrell Wilson

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

View More
View Less

Intervention(s):

drug: 67.5 mg oral insulin crystals daily

drug: 500mg oral insulin crystals every other week

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Trudy Esrey
650-498-4450

©2024 Stanford Medicine