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

NCT02310009 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-02-13

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Anakinra (AN)

BEHAVIORAL

Exercise (EX)

BEHAVIORAL

Control (CON)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Thomas P Solomon, PhD · Rigshospitalet & University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-06-30
Completion
2015-07-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02310009 on ClinicalTrials.gov