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Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β (Hyper-PreDIL)

Primary Purpose

Hyperinsulinemia, PreDiabetes

Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperinsulinemia focused on measuring anakinra (Kineret®)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Intervention

Control Intervention

Arm Description

Patients receive investigational product

Patients receive placebo

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
July 25, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05854251
Brief Title
Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β
Acronym
Hyper-PreDIL
Official Title
Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperinsulinemia, PreDiabetes
Keywords
anakinra (Kineret®)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled, double-blind, randomized, cross-over proof-of-concept study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention
Arm Type
Experimental
Arm Description
Patients receive investigational product
Arm Title
Control Intervention
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo
Intervention Type
Drug
Intervention Name(s)
Anakinra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in insulin concentration following a standardized mixed-meal test
Description
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.
Time Frame
two time assessment at baseline and after 1-2 weeks
Title
Change in glucose concentration following a standardized mixed-meal test
Description
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.
Time Frame
two time assessment at baseline and after 1-2 weeks
Title
Change in c-peptide concentration following a standardized mixed-meal test
Description
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.
Time Frame
two time assessment at baseline and after 1-2 weeks
Title
Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test
Description
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.
Time Frame
two time assessment at baseline and after 1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Donath, Prof.
Phone
+41 61 265 25 25
Email
marc.donath@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Hepprich, MD
Phone
+41 61 265 25 25
Email
matthias.hepprich@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Donath, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Donath, Prof.
Phone
+41 61 265 50 78
Email
marc.donath@usb.ch
First Name & Middle Initial & Last Name & Degree
Matthias Hepprich, MD
Phone
+41 61 265 25 25
Email
matthias.hepprich@usb.ch
First Name & Middle Initial & Last Name & Degree
Marc Donath, MD
First Name & Middle Initial & Last Name & Degree
Matthias Hepprich, MD
First Name & Middle Initial & Last Name & Degree
Justus Fischer, MD
First Name & Middle Initial & Last Name & Degree
Stefanie Dobler, MD

12. IPD Sharing Statement

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Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

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