| Trial ID: | L1965 |
| Source ID: | NCT00928876
|
| Associated Drug: |
Anakinra (Kineret)
|
| Title: |
Interleukin-1 Receptor Antagonist and Insulin Sensitivity
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Insulin Resistance
|
| Interventions: |
DRUG: Anakinra (Kineret)|DRUG: Placebo
|
| Outcome Measures: |
Primary: to determine the effect of Interleukin-1 receptor antagonist on insulin sensitivity, as derived from glucose infusion rate measured by euglycemic hyperinsulinemic clamp, after four weeks of treatment | Secondary: pancreatic beta cell function als tested by oral glucose tolerance test, pro-insulin/insulin ratio, after four weeks of treatment|lipid profile, after four weeks of treatment|systemic inflammation, after four weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Radboud University Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2010-12-17
|
| Locations: |
Rabdoud University Nijmegen Medical Centre, Nijmegen, 6500 HB, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00928876
|
