drugset / Trial / NCT00928876

Interleukin-1 Receptor Antagonist and Insulin Sensitivity

NCT00928876 ↗

Phase 2 Unknown 12 enrolled Radboud University Medical Center
RandomizedCrossoverQuadruple-blindTreatment

Summary

Obesity is characterized by continuous low-grade inflammation. This is an important link between obesity and insulin resistance. Results from the investigators' own group of in vitro and in vivo research on mice show that Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has been shown that interleukin-1 receptor antagonist in human subjects improves glycemic control. The investigators' hypothesis is that this is due to improved insulin sensitivity.

Timeline

Start
2009-06
Primary completion
2010-03
Completion
2010-07

Outcome

Missed primary endpoint

paper insulin sensitivity was not significantly different after anakinra treatment (2.8 × 10(-2) ± 0.5 × 10(-2)) compared with placebo treatment (2.4 × 10(-2) ± 0.3 × 10(-2) μmol/kg(-1) · min(-1) · pmol(-1), P = 0.15). PMID 21508140 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 150 mg Subcutaneous