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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
Sponsor:
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
  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

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

ClinicalTrials.gov processed this record on November 24, 2014