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Interferon-Alpha for Diabetes Mellitus Type 1
This study is currently recruiting patients.
Sponsored by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Warren G Magnuson Clinical Center (CC) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Insulin-Dependent Diabetes Mellitus |
Drug: Oral Interferon-Alpha |
Phase II |
MedlinePlus related topics: Juvenile Diabetes
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy
Official Title: Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus
Expected Total Enrollment: 120
Study start: September 13, 2001
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-alpha) 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of T cell activation markers in an animal model ([3]) and a pilot project in humans (S. Brod, University of Texas, unpublished data).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-alpha versus placebo. Three centers will participate in this protocol (University of Texas Health Science Center in Houston, where the protocol has already been IRB approved, Children's Hospital, St. Paul, MN and NIH, Bethesda, Maryland).
Eligibility
Genders Eligible for Study: Both
Criteria
Location and Contact Information
More Information
Publications
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National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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