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

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ClinicalTrials.gov Identifier: NCT02310009
Recruitment Status : Withdrawn (PI relocated to a different country and coI moved to a different lab.)
First Posted : December 5, 2014
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Brief 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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Anakinra (AN) Behavioral: Exercise (EX) Behavioral: Control (CON) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : December 2014
Estimated Primary Completion Date : June 2015
Actual Study Completion Date : July 30, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Glucose disposition [ Time Frame: 1 day after intervention ]
    The glucose disposal rate during hyperglycemic clamp



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310009


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Thomas P Solomon, PhD Rigshospitalet & University of Copenhagen
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Responsible Party: Thomas Solomon, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02310009    
Other Study ID Numbers: ANEX
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Thomas Solomon, Rigshospitalet, Denmark:
Exercise
IL-1RA
Beta-cell function
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents