Interleukin-1 Receptor Antagonist and Insulin Sensitivity
NCT ID: NCT00928876
Last Updated: 2010-12-17
Study Results
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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UNKNOWN
PHASE2
12 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
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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.
Detailed Description
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Interleukin 6 and Tumor Necrosis Factor alfa are well known pro-inflammatory cytokines that have been linked to insulin resistance. Results from our own group show that interleukin-1 is also involved in the process of developing insulin resistance.
Earlier research projects studied the effect of Interleukin-1 receptor antagonist (Anakinra) on glycemic control in subjects with type 2 diabetes mellitus. It was shown that glycemic control was improved. The authors conclude that this is the result of improved function of pancreatic beta cells.
These results are in contrast to our results of in vitro en in vivo research on mice, which show improved insulin sensitivity by Interleukin-1 receptor antagonist.
A possible explanation for not finding an effect on insulin sensitivity by earlier research projects may be that it is difficult to reliable quantify insulin sensitivity in this group of patients with concurrent changes in glycemic control, extensive co-morbidity and medication use, who might be at the rather extreme end of insulin resistance. Furthermore a relatively low dose of Anakinra was used.
Altogether we hypothesize that the effect of Interleukin-1 is not only mediated through better pancreatic beta-cell function, but that Interleukin-1 blocking by recombinant Interleukin-1 receptor antagonist will also diminish insulin resistance.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Anakinra group
Anakinra 150 mg/day during four weeks
Anakinra (Kineret)
anakinra 150 mg s/c. daily for four weeks
Placebo
Placebo during four weeks
Placebo
placebo s/c daily for four weeks
Interventions
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Anakinra (Kineret)
anakinra 150 mg s/c. daily for four weeks
Placebo
placebo s/c daily for four weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 3 or more characteristics of the metabolic syndrome
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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C J Tack, Prof Dr
Role: STUDY_CHAIR
Radboud University Medical Center
Locations
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Rabdoud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
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References
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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.
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.
Other Identifiers
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UMCN001
Identifier Type: -
Identifier Source: org_study_id