Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

PreDiabetes Clinical Trial

— Hyper-PreDIL  

Official title:

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854251
• Other study ID #: 2023-00497; kt23Donath2
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2023
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Marc Donath, Prof.
• Phone: +41 61 265 25 25
• Email: marc.donath[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperinsulinemia
• Hyperinsulinism
• PreDiabetes
• Prediabetic State

Intervention

Drug:
• Anakinra
Subjects receive an s.c. injection of 100 mg Anakinra on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal
• Placebo
0.67 ml of s.c. injection of saline will be taken on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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