Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024518
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2001-09-19
Brief Title:
Interferon-Alpha for Diabetes Mellitus Type 1
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Ingested Interferon-Alpha Prolongation or Permanence of the Honeymoon Phase in Newly Diagnosed Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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expression of T cell activation markers in an animal model 3 and a pilot project in humans S Brod University of Texas unpublished data The one-year study is designed as a double blind randomized protocol using either 5000 or 30000 units of IFN-a versus placebo Five centers will participate in this protocol University of Texas Health Science Center in Houston Dallas Childrens Hospital St Paul MN Kansas City and NIH Bethesda Maryland
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 5000 or 30000 units of IFN-a versus placebo Five centers will participate in this protocol University of Texas Health Science Center in Houston Dallas Childrens Hospital St Paul MN Kansas City and NIH Bethesda Maryland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-DK-0249 | None | None | None |