Project: Research project

Project Details


Type I or insulin-Dependent Diabetes Mellitus (IDDM) arises in genetically
predisposed individuals as consequence of immune mediated destruction of
the pancreatic islet insulin secreting beta-cells. The onset of clinical
symptoms of diabetes represents the end point of a chronic progressive
decline in beta-cell function, and occurs when the majority of beta-cells
have been lost. Since type 1 diabetes develops insidiously from an
ongoing, immune-mediated destructive process, and it can be predicted with
some degree of accuracy, then it is possible that intervention at a point
in this long prodromal period would prevent the initiation or perpetuation
of beta-cell destruction. A number of potential intervention strategies
exist that may slow the course or prevent the development of type I
diabetes, and/or preserve beta-cell function and thus stabilize
individuals with new onset type 1 diabetes. The Prevent Diabetes Group
(PDG) has been organized on the premise that significant advances can be
made by a cooperative approach to the design and conduct of human clinical
intervention trials both to prevent development of type I diabetes
mellitus and to preserve beta-cell function in recent onset type I
diabetes mellitus. The goal is to create a dynamic and flexible
environment where investigators can work together to develop and implement
research protocols. Each member of the group supports the concept of
inter-institutional studies by pooling clinical case material and
laboratory resources with other collaborating members, and of
participating in study committees for the purpose of developing new ideas
and analyzing or evaluating the results of studies related to the
prevention and/or stabilization of human type I diabetes mellitus. For the
purposes of these studies, the disease is divided into several stages of
development (early, advanced, and late prediabetes; new onset diabetes;
etc.). The purpose of dividing subjects into these disease stages is that
different intervention strategies might be tested in different groups. For
example, one might be willing to accept a greater risk of side effects in
late disease, e.g. new onset type I diabetes, than in any of the stages of
prediabetes. Likewise, one might accept greater risk in late prediabetes
than in early or advanced prediabetes. Moreover, different strategies may
seem more applicable in one category than another. The PDG is made up of
member institutions (clinical centers) and investigators organized into
Committees, and facilitated by an Operations Office, a Statistical Office,
and several Reference Laboratories. This provides the basic stricture for
an ongoing series of trials. The Reference laboratories will assure
standardized, reliable methods are used. Predictive models will be
compared. In addition, we propose to conduct and monitor two pilot and
feasibility studies to test the potential of intervention with [1]
periodic courses of intravenous insulin, with or without accompanying
chronic subcutaneous insulin, and [2] gut antigen presentation by oral
administration of potential autoantigens to induce immunological
Effective start/end date9/30/938/31/05


  • National Institutes of Health
  • National Institutes of Health: $2,042,946.00
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $375,743.00
  • National Institutes of Health: $2,629,292.00
  • National Institutes of Health: $3,631,411.00


  • Medicine(all)


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