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Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2004 by Institute for Clinical and Experimental Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190502
First Posted: September 19, 2005
Last Update Posted: January 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Institute for Clinical and Experimental Medicine
  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
Intervention Model: Parallel Assignment
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00190502     History of Changes
Other Study ID Numbers: KD CD IKEM 1
NB/6541-3 IGA MZCR
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: January 9, 2007
Last Verified: February 2004

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, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs