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NCT Number: NCT05854251

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

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.

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Key information

Conditions

Hyperinsulinemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

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

Drug

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 outcomes

  1. Change in insulin concentration following a standardized mixed-meal test

    Time frame: two time assessment at baseline and after 1-2 weeks

    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.

  2. Change in glucose concentration following a standardized mixed-meal test

    Time frame: two time assessment at baseline and after 1-2 weeks

    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.

  3. Change in c-peptide concentration following a standardized mixed-meal test

    Time frame: two time assessment at baseline and after 1-2 weeks

    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.

  4. Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test

    Time frame: two time assessment at baseline and after 1-2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: Hyper-PreDIL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 11, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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