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Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005665
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2000
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

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 cytokine(s).

We will determine the safety and efficacy of 30,000 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: interferon alpha Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Interferon

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed type 1 diabetes (within one month of diagnosis).
  • IDDM patients: Prepubescent, adolescent, or early adult patients.

Exclusion Criteria:

  • Patients below the age of 3 or over 25.
  • Patients will not be eligible if they are on immunosuppressive or immunostimulatory medications such as azathioprine, oral nicotinamide, superoxide dismutase-desferroxamine, vitamin E, aminoguanidine, oral insulin or other experimental therapies at any time.
  • Patients with a history of alcoholism, renal, cardiac, or pulmonary disease or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program
  • Patients who are pregnant or nursing, or those who are not willing to practice an acceptable birth control method
  • Patients with abnormal pre-treatment values on WBC or who are receiving potentially hepatotoxic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005665

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United States, Texas
Dept. of Neurology, Rm MSB 7.044 Univ. of Texas-Houston Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Layout table for additonal information Identifier: NCT00005665    
Other Study ID Numbers: NCRR-M01RR02558-0135
M01RR002558 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs