PreDiabetes Clinical Trial
— Hyper-PreDILOfficial title:
Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study
The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in insulin concentration following a standardized mixed-meal test | Changes in insulin concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. | two time assessment at baseline and after 1-2 weeks | |
Primary | Change in glucose concentration following a standardized mixed-meal test | Changes in glucose concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. | two time assessment at baseline and after 1-2 weeks | |
Primary | Change in c-peptide concentration following a standardized mixed-meal test | Changes in c-peptide concentration (nmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. | two time assessment at baseline and after 1-2 weeks | |
Primary | Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test | Changes in insulinogenic index (IGI) (I30 - I0)/(G30 - G0) under anakinra compared to placebo.
Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. |
two time assessment at baseline and after 1-2 weeks |
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