NCT02310009

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

December 2, 2014

Last Update Submit

February 10, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

ExerciseIL-1RABeta-cell functionType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Beta-cell function

    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 Outcomes (1)

  • Glucose disposition

    1 day after intervention

Study Arms (4)

Control (CON)

EXPERIMENTAL

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

Behavioral: Control (CON)

Anakinra (AN)

EXPERIMENTAL

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)

Exercise (EX)

EXPERIMENTAL

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)

Anakinra + Exercise (ANEX)

EXPERIMENTAL

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)

Interventions

Anakinra (AN)DRUG
Anakinra (AN)Anakinra + Exercise (ANEX)
Exercise (EX)BEHAVIORAL
Anakinra + Exercise (ANEX)Exercise (EX)
Control (CON)BEHAVIORAL
Control (CON)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with HbA1c \>7%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Interleukin 1 Receptor Antagonist ProteinExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas P Solomon, PhD

    Rigshospitalet & University of Copenhagen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 30, 2015

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

DK(1)