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

Phase 1

• Conditions: diabetes mellitus; MedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2010-023479-24-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-08
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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>7.5%, stable glycemic control
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) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to determine whether blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves insulin sensitivity. ;Secondary Objective: Secondary objectives are to determine wheter blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves adipocyte insulin sensitivity and adipose tissue morphology and changes circulating inflammatory factors, adipokine levels and lipid profile.;Primary end point(s): whole body insulin sensitivity