Interferon-Alpha for Diabetes Mellitus Type 1
- Conditions
- Insulin-Dependent Diabetes Mellitus
- Interventions
- Other: PlaceboDrug: 5,000 hrINF-alphaDrug: 30,000 units hrINF-alpha
- Registration Number
- NCT00024518
- Brief Summary
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.
- Detailed Description
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of T cell activation markers in an animal model (\[3\]) and a pilot project in humans (S. Brod, University of Texas, unpublished data).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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo was prepared as saline alone with 6mg human serum albumin (HSA). Subjects orally ingested one vial each morning before breakfast with at least 150mL water. 5,000 Units hrIFN-alpha 5,000 hrINF-alpha hrIFN-alpha = human recombinant interferon-alpha. 5,000 units was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water. 30,000 hrIFN-alpha 30,000 units hrINF-alpha 30,000 units hrIFN-alpha was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
- Primary Outcome Measures
Name Time Method C-Peptide Level Baseline - 3mth, 6mnth, 9mnth, 12mnth The Connecting Peptide, or C-peptide, is a short 31-amino-acid protein that connects insulin's A-chain to its B-chain in the proinsulin molecule.
- Secondary Outcome Measures
Name Time Method Serum glucose baseline - 3mths, 6mnths, 9mnths, 12mnths Serum glucose or blood sugar measurements determine how much sugar is in the blood.
Hemoglobin A1C Baseline - 3mnths, 6mnths, 9mnths, 12mnths a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Trial Locations
- Locations (5)
University of Texas, Houston
🇺🇸Houston, Texas, United States
Children's Hospital - St. Paul
🇺🇸St. Paul, Minnesota, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States
University of Texas, Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital - Kansas City
🇺🇸Kansas City, Missouri, United States