Project: Research project

Project Details


The overall objective of this research project is to better clarify the
immunopathology associated with Type I insulin dependent diabetes mellitus
(IDDM) and to determine if immune intervention alters the course of IDDM.
The specific aims include: characterization of a cohort of patients with
recent onset IDDM in terms of pancreatic islet beta cell function and
immune parameters thought potentially related to the etiopathogenesis of
IDDM; definition of the relationship between pancreatic islet beta cell
function, various immune parameters, and HLA type; and better definition of
the natural history of residual islet beta cell function and various immune
parameters during the course of IDDM. In addition, this study will
determine the effects of immune intervention with cyclosporine in patients
with recent onset IDDM, including: the frequency of complete remission of
IDDM, one year after onset, in comparison to a placebo treated control
group; the effects of immune intervention with cyclosporine on degree of
diabetic control, residual islet beta cell function, and immune parameters
thought related to pancreatic islet immunogenicity; the relative efficacy
and safety of immune intervention with cyclosporine; the evolution of
diabetic microangiopathy, specifically the appearance of diabetic
retinopathy and of changes in renal function.

The study is a randomized, double-blind, placebo controlled clinical trial
evaluating the effects of cyclosporine in patients with Type I
Insulin-Dependent Diabetes Mellitus commencing within four weeks of
diagnosis. The trial will evaluate up to 100-110 patients, 50-55 patients
with each treatment. Patients will be stratified into three groups, prior
to randomization, based on the degree of severity of IDDM at the time of
initial presentation. Subjects in both treatment categories will be
treated with Intensive Insulin Therapy according to the protocol outlined
below. Outcome will be judged on the basis of the appearance of complete
or partial remissions. Residual endogenous islet beta cell function, as
assessed by C-peptide secretion, will be carefully evaluated on a serial
basis. Both non-specific and pancreatic islet specific immune parameters
will be monitored serially.
Effective start/end date1/1/901/1/90


  • National Institute of Diabetes and Digestive and Kidney Diseases
  • National Institute of Diabetes and Digestive and Kidney Diseases


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