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

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ClinicalTrials.gov Identifier: NCT00190502

Recruitment Status : Unknown

Verified February 2004 by Institute for Clinical and Experimental Medicine.
Recruitment status was: Recruiting

First Posted : September 19, 2005

Last Update Posted : January 9, 2007

Sponsor:

Collaborator:

Ministry of Health, Czech Republic

Information provided by:

Institute for Clinical and Experimental Medicine

Study Description

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 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 or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: Polyclonal anti-T-cell antibodies	Not Applicable

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Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	28 participants
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
Study Start Date :	November 2000
Study Completion Date :	December 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Globulin, Immune

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

C-peptide production

Secondary Outcome Measures :

Diabetes remission rate
Insulin dose

Eligibility Criteria

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 of Results:

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. Rev Diabet Stud. 2004 Summer;1(2):80-8. Epub 2004 Aug 10.


ClinicalTrials.gov Identifier:	NCT00190502 History of Changes
Other Study ID Numbers:	KD CD IKEM 1 NB/6541-3 IGA MZCR
First Posted:	September 19, 2005 Key Record Dates
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 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases	Immune System Diseases Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs

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