NCT00928876

Brief Summary

Obesity is characterized by continuous low-grade inflammation. This is an important link between obesity and insulin resistance. Results from the investigators' own group of in vitro and in vivo research on mice show that Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has been shown that interleukin-1 receptor antagonist in human subjects improves glycemic control. The investigators' hypothesis is that this is due to improved insulin sensitivity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 17, 2010

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 25, 2009

Last Update Submit

December 16, 2010

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Keywords

anakinraDiabetes mellitus, type 2Insulin resistanceInterleukin-1beta

Outcome Measures

Primary Outcomes (1)

  • to determine the effect of Interleukin-1 receptor antagonist on insulin sensitivity, as derived from glucose infusion rate measured by euglycemic hyperinsulinemic clamp

    after four weeks of treatment

Secondary Outcomes (3)

  • pancreatic beta cell function als tested by oral glucose tolerance test, pro-insulin/insulin ratio

    after four weeks of treatment

  • lipid profile

    after four weeks of treatment

  • systemic inflammation

    after four weeks of treatment

Study Arms (2)

Anakinra group

EXPERIMENTAL

Anakinra 150 mg/day during four weeks

Drug: Anakinra (Kineret)

Placebo

PLACEBO COMPARATOR

Placebo during four weeks

Drug: Placebo

Interventions

Anakinra (Kineret)DRUG

anakinra 150 mg s/c. daily for four weeks

Also known as: kineret
Anakinra group
PlaceboDRUG

placebo s/c daily for four weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult subjects with a BMI \> 30 kg/m2
  • or more characteristics of the metabolic syndrome

You may not qualify if:

  • inability to give informed consent
  • age \< 18 years
  • known diabetes mellitus
  • fasting plasma glucose \> 7,0 mmol/l or HbA1c \> 6,2%
  • presence of any medical condition that might interfere with the current study protocol
  • immunodeficiency of immunosuppressive treatment
  • anti-inflammatory drugs (100 mg of aspirin/day is allowed)
  • signs of current infection
  • history of recurrent infections
  • pregnancy or breast feeding
  • liver disease
  • renal disease
  • neutropenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabdoud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

  • Larsen CM, Faulenbach M, Vaag A, Volund A, Ehses JA, Seifert B, Mandrup-Poulsen T, Donath MY. Interleukin-1-receptor antagonist in type 2 diabetes mellitus. N Engl J Med. 2007 Apr 12;356(15):1517-26. doi: 10.1056/NEJMoa065213.

    PMID: 17429083BACKGROUND

  • van Asseldonk EJ, Stienstra R, Koenen TB, Joosten LA, Netea MG, Tack CJ. Treatment with Anakinra improves disposition index but not insulin sensitivity in nondiabetic subjects with the metabolic syndrome: a randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2011 Jul;96(7):2119-26. doi: 10.1210/jc.2010-2992. Epub 2011 Apr 20.

    PMID: 21508140DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • C J Tack, Prof Dr

    Radboud University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

December 17, 2010

Record last verified: 2009-06

Locations

NL(1)