Trials / Terminated

TerminatedNCT04227769

IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 18 (actual)

Sponsor: University Hospital, Basel, Switzerland · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Accepted

Summary

A prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2).

Detailed description

The role of the immune system in metabolism has been extensively investigated in pancreatic islets and insulin sensitive tissues. However little attention has been given to a potential role of the innate immune system in the cephalic phase of insulin secretion. In humans, the cephalic phase of insulin secretion appear reduced in obesity and in patients with type 2 diabetes. In this prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial we aim to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2). Group 1: After screening, subjects will be randomized to two crossover visits with a washout period of at least 4 days in-between visits and at most two weeks: A) subcutaneous saline injection 3h before an oral standardized meal, B) subcutaneous injection of 100 mg of the IL-1 receptor antagonist anakinra 3h before an oral standardized meal. Treatments will be placebo controlled, crossover, double blinded. The study will be performed in a population of healthy individuals. Group 2: Same as for Group 1 with the following addition: after the second study day, participant in group 2 will be trained to self-inject the medication for 6 days. On the 7th day, an oral standardized meal test will be performed. Healthy subjects from group 1 will be matched for sex and age to the diabetic cohort from group 2.

Conditions

Interventions

Type	Name	Description
DRUG	Anakinra Prefilled Syringe	Subcutaneous injection of 100 mg/ 0.67 ml of Kineret or placebo

Timeline

Start date: 2020-01-13
Primary completion: 2024-05-28
Completion: 2024-05-28
First posted: 2020-01-14
Last updated: 2025-01-29

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04227769. Inclusion in this directory is not an endorsement.