Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2004 by Institute for Clinical and Experimental Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Institute for Clinical and Experimental Medicine
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00190502
First received: September 11, 2005
Last updated: January 8, 2007
Last verified: February 2004
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Purpose
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
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: Polyclonal anti-T-cell antibodies |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
| Official Title: | The Use of Polyclonal Anti-T-Lymphocyte Globulin to Prevent Progression of Autoimmune Beta-Cell Destruction in Recent Type 1 Diabetes |
Resource links provided by NLM:
Further study details as provided by Institute for Clinical and Experimental Medicine:
Primary Outcome Measures:
- C-peptide production
Secondary Outcome Measures:
- Diabetes remission rate
- Insulin dose
| Estimated Enrollment: | 28 |
| Study Start Date: | November 2000 |
| Estimated Study Completion Date: | December 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- Other non-diabetes related autoimmune disease
- Previous immunosuppressive therapy
- Any clinical impairment precluding immunosuppressive therapy
- Leucopenia or thrombocytopenia
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190502
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190502
Contacts
| Contact: Frantisek Saudek, MD. | frsa@medicon.cz |
Locations
| Czech Republic | |
| Institute for Clinical and Experimental Medicine, Department of Diabetes | Recruiting |
| Prague, Czech Republic, 14021 | |
| Contact: Frantisek Saudek, MD. frsa@medicon.cz | |
| Principal Investigator: Frantisek Saudek, MD | |
| Sub-Investigator: Petr Boucek, MD. | |
| Sub-Investigator: Tereza Havrdova | |
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Ministry of Health, Czech Republic
Investigators
| Study Chair: | Frantisek Saudek, MD. | Institute for Clinical and Experimental Medicine, Prague |
More Information
Publications:
Saudek F., Havrdova T., Boucek P., Karasova L., Novota P., Skibova J.: Polyclonal anti-T-cell therapy for type 1 diabetes mellitus of recent onset. Review of Diabetic Studies 1, 2004: 80-88.
| ClinicalTrials.gov Identifier: | NCT00190502 History of Changes |
| Other Study ID Numbers: | KD CD IKEM 1, NB/6541-3 IGA MZCR |
| Study First Received: | September 11, 2005 |
| Last Updated: | January 8, 2007 |
| Health Authority: | Czech Republic: Ministry of Health |
Keywords provided by Institute for Clinical and Experimental Medicine:
|
Type 1 diabetes mellitus Immune intervention Polyclonal antibodies |
Type 1 diabetes of recent onset C-peptide level 0.3 pmol/l or higher Positivity of at least one marker of autoimmunity (diabetes) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Autoimmune Diseases Endocrine System Diseases |
Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015