Oral Insulin for Prevention of Diabetes

Protocol ID

07.10.045

Protocol Description

This study’s aim is to delay or prevent the onset of disease in relatives at high risk of getting  type 1 diabetes mellitus (T1DM). T1DM is a condition caused by the lack of insulin, the hormone  controlling the ability to process glucose. This leads to high blood sugar levels, which in turn can cause a host of other problems if the disease is not recognized or properly treated. People with T1DM have an inherited tendency toward an immune system attack against the body's own insulin-producing cells, and in this process different types of autoantibodies (factors that can damage human tissues and organs) are formed. One class of antibodies are insulin autoantibodies. We can detect autoantibodies linked to diabetes up to 10 years before diabetes develops. There is some evidence from prior studies that in certain people with high levels of insulin autoantibodies, oral insulin may delay diabetes onset. This new study is being done to confirm whether oral insulin clearly delays or prevents diabetes.

Eligibility Criteria

Patients who have a close relative with type 1 diabetes, and are at high risk of getting type 1 diabetes mellitus (T1DM)

Primary Investigator(s)

  • Phyllis W. Speiser, MD

Contact Information

Margaret Pellizzari, RN
(718) 470-3290
mpellizz@nshs.edu

Last Update

March 30, 2010
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