The Effect of Anakinra on Insulin Secretion

March 23, 2012 updated by: Radboud University Medical Center

The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction

Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.

Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
  • BMI >25 kg/m2
  • Age 40-70 years

Exclusion Criteria:

  • Known diabetes mellitus
  • Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
  • Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
  • Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
  • Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
  • A history of recurrent infections
  • Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
  • Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
  • Renal disease defined as MDRD < 60 ml/min/1.73m2
  • Neutropenia < 2x 109/L
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Any medical condition that might interfere with the current study protocol
  • Participation in a drug trial within 60 days prior to the first dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anakinra
Anakinra 150 mg/day during four weeks
Drug: Anakinra
150 mg sc once daily during four weeks
Other Names:
  • Kineret
  • Interleukin1-receptor antagonist
Placebo Comparator: Placebo
Placebo during four weeks
Drug: Anakinra
150 mg sc once daily during four weeks
Other Names:
  • Kineret
  • Interleukin1-receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
Time Frame: after 4 weeks of treatment with anakinra
after 4 weeks of treatment with anakinra

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the effect on anakinra on insulin sensitivity.
Time Frame: after 4 week treatment of anakinra
Oral glucose tolerance test
after 4 week treatment of anakinra
Effects of anakinra on fat cell morphology and gene expression
Time Frame: after 4 weeks of treatment with anakinra
Fatbiopsy
after 4 weeks of treatment with anakinra

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: C.J. Tack, MD, PhD, Prof. of Diabetology, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anakinra1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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