Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β (Hyper-PreDIL)
Hyperinsulinemia, PreDiabetes
About this trial
This is an interventional treatment trial for Hyperinsulinemia focused on measuring anakinra (Kineret®)
Eligibility Criteria
Inclusion Criteria: Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l. BMI ≥ 28 kg/m2 Age ≥ 18 years C-reactive protein ≥ 2 mg/dl For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study Exclusion Criteria: Upper gastrointestinal surgery Diagnosis of any type of diabetes mellitus Signs of current infection Use of any glucose lowering medication within the last three months Use of investigational drug up to one week prior to start of treatment phase. Anti-inflammatory medication, including systemic glucocorticoid therapy. Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L) Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females) Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN) Uncontrolled disease Currently pregnant or breastfeeding No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study
Sites / Locations
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental Intervention
Control Intervention
Patients receive investigational product
Patients receive placebo