Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	01-DK-0249
Sponsoring Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 3 Max Age: 25
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Diabetes; Immunotherapy; Study Drug
Recruitment Keyword(s)	Insulin Dependent Diabetes; Diabetes; Diabetes Mellitus; TIBM
Condition(s)	Insulin-Dependent Diabetes Mellitus
Investigational Drug(s)	Oral Interferon-Alpha
Investigational Device(s)	None
Intervention(s)	Drug: Oral Interferon-Alpha
Supporting Site	National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

INCLUSION CRITERIA:

T1DM of less than 6 weeks duration in patients between 3 and 25 years of age.

Besides T1DM, no concurrent illness.

EXCLUSION CRITERIA:

Treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.

Abnormal pre-treatment white blood cell count (WBC) or thrombocytopenia.

Known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.

History of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.

Ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.

Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Inability to give informed consent or assent.

Participation in a clinical trial within the previous 6 weeks.

Lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).

Age above 25 years, since there may be several subtypes of T1DM.

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Citations:

The pathogenesis of insulin-dependent diabetes mellitus

Type I diabetes mellitus A chronic autoimmune disease

Ingested interferon alpha suppresses type I diabetes in non-obese diabetic mice

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Contacts:

Principal Investigator	Referral Contact	For more information:
Kristina I. Rother, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 8C432A MSC 1756 10 CENTER DR BETHESDA MD 20892-1756 (301) 435-4639 kristinar@intra.niddk.nih.gov	Michelle L. Ashmus, R.N. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 7C432B 10 Center Drive Bethesda, Maryland 20892 (301) 594-5953 ashmusm@ninds.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00024518

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