Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005665
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-05-19
Brief Title:
Ingested Interferon Alpha Prolongation or Permanence of the Honeymoon Phase in Newly Diagnosed Type 1 Diabetes Mellitus
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
We hypothesize that ingested human recombinant interferon-alpha hrIFN-a will prolong the honeymoon period and enhance B cell survival in type 1 diabetes in a phase II randomized placebo-controlled double-blind clinical trial We have demonstrated that ingested IFN-a prevents type 1 diabetes in the NOD mouse prolongs the honeymoon period in newly diagnosed type 1 diabetics and delays murine islet allograft rejection The natural history of type 1 diabetes is unique for a phase frequently referred as the honeymoon a period in which the insulin need becomes minimal and glycemic control improves The B cell the insulin producing cell partially recovers However as with all honeymoons they end and the patient becomes completely insulin-deficient The general consensus of the international diabetes community is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients Prolongation of the honeymoon as the reversal of the disease is considered a positive result
In this phase II randomized double-blind parallel-design clinical trial we will determine whether ingested oral human recombinant IFN-a will prolong the honeymoon period and increase counterregulatory anti-inflammatory cytokines
We will determine the safety and efficacy of 30000 units ingested hrIFN-a vs placebo in eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year Primary outcome measures will be a 30 increase in C-peptide levels released after Sustacal stimulation at 3 6 9 and 12 months after entry Secondary outcome will be decreasing titers of islet cell antibodies ICA If successful a larger and longer phase III trial of prevention of type 1 diabetes in high risk patients will be undertaken We will also determine if ingested hrIFN-a increases IL-4 IL-10 or IFN-a production in peripheral blood mononuclear cells PMNC from patients with recent onset type 1 diabetes
In this phase II randomized double-blind parallel-design clinical trial we will determine whether ingested oral human recombinant IFN-a will prolong the honeymoon period and increase counterregulatory anti-inflammatory cytokines
We will determine the safety and efficacy of 30000 units ingested hrIFN-a vs placebo in eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year Primary outcome measures will be a 30 increase in C-peptide levels released after Sustacal stimulation at 3 6 9 and 12 months after entry Secondary outcome will be decreasing titers of islet cell antibodies ICA If successful a larger and longer phase III trial of prevention of type 1 diabetes in high risk patients will be undertaken We will also determine if ingested hrIFN-a increases IL-4 IL-10 or IFN-a production in peripheral blood mononuclear cells PMNC from patients with recent onset type 1 diabetes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR002558 | NIH | None | httpsreporternihgovquickSearchM01RR002558 |