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

• Status: Withdrawn
• Trial end date: 2015-07-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Type 2 diabetes with HbA1c >7%

Exclusion Criteria:

• HbA1c >7%

• Age <30 or >80 y

• BMI <25 or >40 kg/m2

• Pregnancy

• Evidence of chronic haematological/renal/hepatic/pulmonary/heart disease

• >2kg weight change in prior 6 months

• Alcohol consumption (men: >14 drinks/week; women: >7 drinks/week)

• Smoking

• Physical activity of >150 min/week

• Contraindication to exercise

• Contraindication to use of anakinra