Posted by Staley A. Brod MD on August 29, 2000 at 13:20:26:
THE UNIVERSITY OF TEXAS DIABETES RESEARCH GROUP NEWSLETTER presents new information on studies of oral (ingested) type I interferon. The Endocrinology Divisions in both Internal Medicine and Pediatrics are now recruiting newly diagnosed type 1 diabetes patients in a phase II randomized, double-blind, parallel-design clinical trial to determine whether ingested (oral) human recombinant IFN-a will prolong the ‘honeymoon’ period. We have demonstrated that ingested IFN-a prevents type 1 diabetes in the NOD mouse. Ingested IFN-a also prolongs the ‘honeymoon’ period in newly diagnosed type 1 diabetics in phase I open label clinical trial recently completed here at UT-Houston. 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 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.
Entry criteria include male or female type 1 diabetes patients requiring insulin within one month of diagnosis between the ages of 3-25 without concurrent diseases. Eighty eligible patients will be randomized into one of two treatment arms - the active treatment arm will ingest 30,000 units IFN-a daily and the non-active treatment arm will ingest placebo (saline) for one year.
Prior to enrollment into the study (within 1 month of diagnosis), patients will be evaluated in the UT University Clinical Research Center at Hermann Hospital with a complete medical exam and routine blood tests. Patients will be seen monthly for the first three months, and every three months thereafter. 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. If successful, this will lead to a larger and longer phase III trial of prevention of type 1 diabetes in high risk patients.
There is no charge to patients. Patients will continue to be followed by their private endocrinologist for optimization of glycemic control during the course of the study. This trial will require trips to Houston at entry and at months 1, 2, 3, 6, 9, and 12 for testing.
If you know of patients that might wish to participate in this clinical trial outlined above, please call any of the numbers below.
Staley A. Brod, MD Principal Investigator - 713 500-7046 or 713 500-7050, Fax:713-500-7041 (PI)
Phil Orlander, MD Adult Endocrinology - Co- Principal Investigator 713-500-6646
Victor Lavis, M.D. Adult Endocrinology
Patrick Brosnan, M.D. Pediatric Endocrinology - 713-500-5646
Lucie Lambert, Asst. to Dr. Brod 713 500-7050.
The University of Texas –
Houston.
Department of Pediatrics, Internal Medicine, and Neurology (Immunology)
6431 Fannin St
Houston, Texas 77030