The effect of interleukin-1 receptor antagonist on insulin secretion - Anakinra and insulin secretio
Phase 1
- Conditions
- Beta-cell dysfunctionMedDRA version: 12.1Level: LLTClassification code 10052341Term: Impaired insulin secretion
- Registration Number
- EUCTR2010-019660-36-NL
- Lead Sponsor
- MC St Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Known diabetes mellitus
- Fasting plasma glucose > 7.0 mmol/L or HbA1c > 6.5%
- Elevated risk for infections
- Pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine whether blocking interleukin-1 by recombinant human interleukin-1 receptor antagonist (IL-1ra) improves beta-cell function in subjects with impaired beta-cell function .;Secondary Objective: Secondary Objective(s): <br>•To determine the effect of IL-1 blockade on insulin sensitivity following four week treatment with anakinra and placebo<br>• To determine the effect of IL-1 blockade on fat cell morphology, fat cell insulin sensitivity and fat cell gene expression following four week treatment with anakinra and placebo.<br>•To determine the effect of IL-1 blockade on plasma levels of inflammatory markers and adipokines following four week treatment with anakinra and placebo. <br>;Primary end point(s): Insulin secretion
- Secondary Outcome Measures
Name Time Method