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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. C-peptide production

Secondary Outcome Measures :

1. Diabetes remission rate
2. Insulin dose

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
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