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

NCT ID: NCT02310009

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-30

Brief Summary

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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).

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control (CON)

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

Group Type EXPERIMENTAL

Control (CON)

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Anakinra (AN)

Intervention Type DRUG

Exercise (EX)

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

Group Type EXPERIMENTAL

Exercise (EX)

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Anakinra (AN)

Intervention Type DRUG

Exercise (EX)

Intervention Type BEHAVIORAL

Interventions

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Anakinra (AN)

Intervention Type DRUG

Exercise (EX)

Intervention Type BEHAVIORAL

Control (CON)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Solomon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas P Solomon, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet & University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ANEX

Identifier Type: -

Identifier Source: org_study_id

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