The effect of interleukin-1 receptor antagonist on insulin secretion in subjects with β-cell dysfunction.

Recruiting

• Conditions: Insulin secretion; 10018424

• Registration Number: NL-OMON34308
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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

Exclusion Criteria

- Known diabetes mellitus
- Fasting plasma glucose > 7.0 mmol/L or HbA1c > 6.5%
- Elevated risk for infections
- Pregnancy or breast-feeding
- Impaired liver and/or renal function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Insulin secretion, as derived from insulin concentrations and glucose<br /><br>concentrations measured by hyperglycemic clamps following 4 week treatment with<br /><br>anakinra and placebo. In addition an oral glucose tolerance test will be<br /><br>performed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of a four week treatment with anakinra compared to placebo on<br /><br>insulin sensitivity.<br /><br><br /><br>Signs of inflammation following treatment with anakinra versus placebo,<br /><br>assessed by<br /><br>• Cytokines (IL-1, IL-6, IL-18, hs CRP)<br /><br>• White blood count<br /><br>• Adipokines (leptin, adiponectin)<br /><br><br /><br>Local effects on fat tissue following treatment with both anakinra and placebo<br /><br>, assessed by<br /><br>• Fat cell size and morphology<br /><br>• Gene expression<br /><br>• Fat cell insulin sensitivity</p><br>