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Type 2 Diabetes MellitusANEXNCT02310009

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

A study testing Anakinra (AN) and Exercise (EX) in people with Type 2 Diabetes Mellitus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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]… Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Anakinra (AN) and Exercise (EX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteDenmark
Study dates
Dec 2014to 30 Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes with HbA1c >7%

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

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).

Being tested
Anakinra (AN), Exercise (EX), Control (CON)
Keywords
Exercise, IL-1RA, Beta-cell function, Type 2 Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anakinra (AN)Drug

  • Exercise (EX)Behavioural

  • Control (CON)Behavioural

Study groups in NCT02310009
Study groupRoleWhat they receive
Control (CON)ExperimentalPlacebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
Receives: Behavioral: Control (CON)
Anakinra (AN)Experimental100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
Receives: Drug: Anakinra (AN)
Exercise (EX)Experimental1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Receives: Behavioral: Exercise (EX)
Anakinra + Exercise (ANEX)Experimental100 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.
Receives: Drug: Anakinra (AN); Behavioral: Exercise (EX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day after intervention

Secondary outcomes (1)

  1. Glucose disposition

    The glucose disposal rate during hyperglycemic clamp

    Measured: 1 day after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completion30 Jul 2015

Why it stopped: PI relocated to a different country and coI moved to a different lab.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02310009
Sponsor's protocol ID
ANEX
Acronym
ANEX
Status last verified
Feb 2017
First submitted
2 Dec 2014
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Anakinra (AN) and Exercise (EX) in people with Type 2 Diabetes Mellitus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beta-cell function (time frame: 1 day after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02310009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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