Effect of Interleukin-1 receptor antagonist on insulin sensitivity in subjects with type 1 diabetes mellitus.

Phase 2

Completed

• Conditions: diabetes; diabetes mellitus; 10018424

• Registration Number: NL-OMON34115
• 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: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Type 1 diabetes with absence of residual Beta-cell function
Age 18-65 yrs
Body mass index of > 25 kg/m2
Insulin requirement > 0.5 U/kg bodyweight
HbA1c > 8.5% for the last 6 months

Exclusion Criteria

Inability to give informed consent
Presence of any medical condition that might interfere with the current study protocol.
Immunodeficiency or immunosuppressive treatment (including TNFa blocking agents and corticosteroids)
Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or less of aspirin per day is allowed)
Signs of current infection (fever, C-reactive protein (CRP) > 30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis.
A history of recurrent infections
Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
Renal disease (creatinine > 130 µmol/l
Neutropenia < 2 x 109/l

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>insulin sensitivity as determined by the euglycemic hyperinsulinemic clamp<br /><br>technique</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>glycemic control<br /><br>adipocyte insulin sensitivity<br /><br>changes in circulating hormonal and inflammatory factors and lipid profile.</p><br>