drugset / Trial / NCT02310009

IL-1RA, Acute Exercise, and Beta-cell Function

NCT02310009

RandomizedParallel-groupDouble-blindBasic science

Summary

Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c\>7%) will be assigned to one of the 4 following interventions in a randomised, parallel group design: \[I\] Control (placebo injection; no exercise), \[II\] Anakinra (100 mg subcutaneous injection of human recombinant interleukin-1 receptor antagonist), \[III\] Exercise (1 h cycle ergometry at 75% VO2max), \[IV\] Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).

Timeline

Start
2014-12
Primary completion
2015-06
Completion
2015-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous