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The Use of Polyclonal Anti-T-Lymphocyte Globulin to Prevent Progression of Autoimmune Beta-Cell Destruction in Recent Type 1 Diabetes
The primary objective of the study is: * To compare the effect of ATG treatment together with intensified insulin therapy (Group 1) on fasting and glucagon-stimulated C-peptide production with that of intensified insulin therapy only (Group 2) in type 1 diabetes mellitus of recent onset Secondary objectives are: * To compare the insulin doses between the two groups at 6, 12, 18, and 24 months after diabetes onset * To compare the course of the specific humoral markers of autoimmunity between the groups * To evaluate the significance of in vitro testing of specific T-cell activation by an autoantigen in the long-term follow-up in type 1 diabetes * To assess the safety of ATG treatment in type 1 diabetes
Details
| Lead sponsor | Institute for Clinical and Experimental Medicine |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 28 |
| Start date | 2000-11 |
| Completion | 2007-12 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- Polyclonal anti-T-cell antibodies
Primary outcomes
- C-peptide production
Countries
Czechia