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[IP] Medical Research for Newly Diagnosed Type 1


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 
=91honeymoon=92 period.  We have demonstrated that ingested IFN-a 
prevents type 1 diabetes in the NOD mouse.  Ingested IFN-a also 
prolongs the =91honeymoon=92 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 

We appreciate your help in referring patients to our Diabetes 
Research Group.  Your efforts allow patients the opportunity to be 
involved in cutting edge clinical trials.  There is no charge to your 
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 have or 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 =96  Houston.   

Department of Pediatrics, Internal Medicine, and Neurology (Immunology)
6431 Fannin St
Houston, Texas 77030

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