Interleukin-1 Receptor Antagonist and Insulin Sensitivity

• Status: Unknown status
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Obesity is characterized by continuous low-grade inflammation. This is an important link between obesity and insulin resistance.

Results from the investigators' own group of in vitro and in vivo research on mice show that Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has been shown that interleukin-1 receptor antagonist in human subjects improves glycemic control. The investigators' hypothesis is that this is due to improved insulin sensitivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Treatments: Insulin; Insulin, Globin Zinc; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• adult subjects with a BMI > 30 kg/m2

• 3 or more characteristics of the metabolic syndrome

Exclusion Criteria:

• inability to give informed consent

• age < 18 years

• known diabetes mellitus

• fasting plasma glucose > 7,0 mmol/l or HbA1c > 6,2%

• presence of any medical condition that might interfere with the current study protocol

• immunodeficiency of immunosuppressive treatment

• anti-inflammatory drugs (100 mg of aspirin/day is allowed)

• signs of current infection

• history of recurrent infections

• pregnancy or breast feeding

• liver disease

• renal disease

• neutropenia