IL-1RA, Acute Exercise, and Beta-cell Function (ANEX)

February 10, 2017 updated by: Thomas Solomon, Rigshospitalet, Denmark
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control (CON)
Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
Behavioral: Control (CON)
Experimental: Anakinra (AN)
100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
Drug: Anakinra (AN)
Experimental: Exercise (EX)
1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Behavioral: Exercise (EX)
Experimental: Anakinra + Exercise (ANEX)
100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus followed by 1 hour of cycling exercise at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Drug: Anakinra (AN)
Behavioral: Exercise (EX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-cell function
Time Frame: 1 day after intervention
A hyperglycemic clamp will be performed combined with glucagon-like peptide(GLP)-1 infusion and arginine injection. The primary outcome is the insulin secretory response to glucose, GLP-1, and arginine.
1 day after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose disposition
Time Frame: 1 day after intervention
The glucose disposal rate during hyperglycemic clamp
1 day after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Thomas P Solomon, PhD, Rigshospitalet & University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Actual)

July 30, 2015

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Control (CON)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe