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Series GSE37025 Query DataSets for GSE37025
Status Public on Oct 01, 2015
Title Interleukin-1 receptor antagonist for recent-onset type 1 diabeties mellitus: a multicenter randomized, placebo-controlled trial
Organism Homo sapiens
Experiment type Expression profiling by array
Summary Background: Blocking the action of the pro-inflammatory cytokine interleukin-1 (IL-1) reduces beta-cell secretory dysfunction and apoptosis in vitro, diabetes incidence in animal models of Type 1 diabetes mellitus (T1D), and glycaemia via improved beta-cell function in patients with T2D. We hypothesised that anakinra, a recombinant human IL-1 receptor antagonist, improves beta-cell function in patients with new-onset T1D. Methods: In an individually randomised, two-group parallel trial involving 14 European tertiary referral centers, 69 patients aged 18-35 with T1D, < 12 weeks of symptoms, and standard mixed meal test (MMT) stimulated C-peptide ≥ 200 pM were enrolled between January, 2009 and July, 2011 and assigned by centralised computer-generated blocked randomisation with locked computer-file concealment to treatment with 100 mg anakinra (n=35) subcutaneously once daily or placebo (n=34) for 9 months as add-on to conventional therapy. Participants and care-givers, but not data monitoring unit, were masked to group assignment. The primary end-point was change in the two-hour area-under-the-curve C-peptide response to MMT, and secondary end-points changes in insulin requirements, glycaemia, and inflammatory markers at one, three, six, and nine months. Findings: The study was prematurely terminated due to slow accrual and is closed to follow-up. No interim analysis was performed. Ten patients withdrew in the anakinra and eight in the placebo arm, leaving 25 and 26 patients to be analysed, respectively. There was no statistical difference in adverse event category reporting between arms. Interpretation: Anakinra-treatment in T1D was safe, but the trial failed to meet primary and secondary outcome measures.
 
Overall design Transcriptional signatures were induced in healthy cryopreserved human donor peripheral blood mononuclear cells (UPN727) through exposure to 40% subject serum in a 9 hour co-culture. Twenty-four randomly selected subjects (13 anakinra treatment; 11 placebo treatment) were analysed blindedly to treatment assignment. The statistical significance of differential gene expression was determined through ANalysis Of VAriation (ANOVA) and false discovery rates (FDR) using Partek Genomics Suite 6.5.

Contributor: The Anti-Interleukin-1 in Diabetes Action (AIDA) study group
 
Contributor(s) Hessner M, Jia S
Citation(s) 26692253
Submission date Apr 04, 2012
Last update date Mar 25, 2019
Contact name Martin Hessner
E-mail(s) mhessner@mcw.edu
Organization name Medical College of Wisconsin
Department Pediatrics
Lab Max McGee National Research Center for Juvenile Diabetes
Street address 8701 Watertown Plank Road
City Milwaukee
State/province WI
ZIP/Postal code 53226
Country USA
 
Platforms (1)
GPL570 [HG-U133_Plus_2] Affymetrix Human Genome U133 Plus 2.0 Array
Samples (235)
GSM1660331 UPN727 cells, AIDA AK01 at baseline
GSM1660332 UPN727 cells, AIDA AK01 at 1 month
GSM1660333 UPN727 cells, AIDA AK01 at 3 month
Relations
BioProject PRJNA157863

Download family Format
SOFT formatted family file(s) SOFTHelp
MINiML formatted family file(s) MINiMLHelp
Series Matrix File(s) TXTHelp

Supplementary file Size Download File type/resource
GSE37025_RAW.tar 975.6 Mb (http)(custom) TAR (of CEL)
Processed data included within Sample table
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