Insulin-Dependent Diabetes Mellitus Clinical Trial
Official title:
Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus
This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.
Type 1 diabetes mellitus (T1DM) results from autoimmune destruction of the insulin-producing
pancreatic beta-cells. The onset of clinical symptoms represents the endpoint of a chronic
progressive decline in beta-cell function when the number of functional beta-cells descends
below the critical mass required for maintenance of euglycemia ([1], [2]). However, the
pancreas still retains the ability to produce a substantial amount of insulin. The goal of
secondary prevention in T1DM is to avert further destruction of the remaining beta-cells and
therefore delay or stop entry into the final stages of the disease associated with end organ
damage.
The rationale for this study is to interfere with the autoimmune beta-cell destruction early
on in order to preserve as much residual endogenous insulin production as possible. We plan
to administer oral interferon-alpha (IFN-a) on a daily basis, which has been shown to modify
the clinical course of diabetes, to alter cytokine release, and reduce expression of T cell
activation markers in an animal model ([3]) and a pilot project in humans (S. Brod,
University of Texas, unpublished data). The one-year study is designed as a double blind
randomized protocol using either 5,000 or 30,000 units of IFN-a versus placebo. Five centers
will participate in this protocol (University of Texas Health Science Center in Houston;
Dallas; Children's Hospital, St. Paul, MN; Kansas City and NIH, Bethesda, Maryland).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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