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

Sponsors

Lead sponsor: Rigshospitalet, Denmark

Source 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).

Overall Status Withdrawn
Start Date December 2014
Completion Date July 30, 2015
Primary Completion Date June 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Beta-cell function 1 day after intervention
Secondary Outcome
Measure Time Frame
Glucose disposition 1 day after intervention
Condition
Intervention

Intervention type: Drug

Intervention name: Anakinra (AN)

Intervention type: Behavioral

Intervention name: Exercise (EX)

Intervention type: Behavioral

Intervention name: Control (CON)

Arm group label: Control (CON)

Eligibility

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

Gender: All

Minimum age: 30 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Thomas P Solomon, PhD Principal Investigator Rigshospitalet & University of Copenhagen
Location
facility Rigshospitalet
Location Countries

Denmark

Verification Date

February 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Rigshospitalet, Denmark

Investigator full name: Thomas Solomon

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Control (CON)

Arm group type: Experimental

Description: Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.

Arm group label: Anakinra (AN)

Arm group type: Experimental

Description: 100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.

Arm group label: Exercise (EX)

Arm group type: Experimental

Description: 1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.

Arm group label: Anakinra + Exercise (ANEX)

Arm group type: Experimental

Description: 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.

Acronym ANEX
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov