Status:
UNKNOWN
Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
Ministry of Health, Czech Republic
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
15-35 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
This is a randomized, controlled, single-blind and parallel group study. After admission to the hospital, initial physical and laboratory examinations will be performed. Laboratory tests and medical t...
Eligibility Criteria
Inclusion
- Type 1 diabetes
- Body mass index up to 32 kg/m2
- Exclusion of gravidity in women
- Known diagnosis of diabetes of less than 6 weeks
- Insulin dose of up to 40 IU per day for no longer than 1 month
- Positive for at least one autoantibody (GAD, IA2, ICA)
- C-peptide level ≥ 0.3 pmol/ml 4 min. following intravenous (IV) administration of 1 ml glucagon
- No concurrent severe infection
- Granulocyte count ≥ 2 x 10\^9/l
- Platelet count ≥ 120 x 10\^9/l
Exclusion
- Other non-diabetes related autoimmune disease
- Previous immunosuppressive therapy
- Any clinical impairment precluding immunosuppressive therapy
- Leucopenia or thrombocytopenia
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00190502
Start Date
November 1 2000
End Date
December 1 2007
Last Update
January 9 2007
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine, Department of Diabetes
Prague, Czechia, 14021