Clinical trial NCT05854251: Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β
Official title: Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperinsulinemia
PreDiabetes
Keywords: anakinra (Kineret®)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled, double-blind, randomized, cross-over proof-of-concept study
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change in insulin concentration following a standardized mixed-meal test
timeFrame: two time assessment at baseline and after 1-2 weeks
measure: Change in glucose concentration following a standardized mixed-meal test
timeFrame: two time assessment at baseline and after 1-2 weeks
measure: Change in c-peptide concentration following a standardized mixed-meal test
timeFrame: two time assessment at baseline and after 1-2 weeks
measure: Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test
timeFrame: two time assessment at baseline and after 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marc Donath, Prof.
role: PRINCIPAL_INVESTIGATOR
References: