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Clinical Trial Details

Trial ID: L3767
Source ID: NCT04227769
Associated Drug: Anakinra Prefilled Syringe
Title: IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes
Acronym: Cephalira
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2 in Obese|Inflammation|Metabolic Disease|Glucose Metabolism Disorders (Including Diabetes Mellitus)
Interventions: DRUG: Anakinra Prefilled Syringe
Outcome Measures: Primary: Change in insulin concentration in blood during the cephalic phase of insulin secretion in healthy individuals, Insulin concentration in blood at 0, 3,6 and 10 minutes after ingestion of a standardized meal in healthy individuals., 10 minutes|Change in insulin concentration in blood during the cephalic phase of insulin secretion in obese patients with type 2 diabetes, Insulin concentration in blood at 0, 3, 6 and 10 minutes after ingestion of a standardized meal in healthy individuals in obese patients with type 2 diabetes., 10 minutes | Secondary: Change of C-peptide, Plasma level of c-peptide before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of insulin, Plasma level of insulin before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of glucose, Plasma level of glucose before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of glucagon, Plasma level of glucagon before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of GLP-1, Plasma level of GLP-1 before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of pancreatic polypeptide, Plasma level of pancreatic polypeptide before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of IL-1β, Plasma level of IL-1β before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of IL-6, Plasma level of IL-6 before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change of IL-1Ra, Plasma level of IL-1Ra before and after a meal through nasogastric tube or with anakinra or placebo after a standardized meal., 6 hours|Change of TNFa, Plasma level of TNFa before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|change in hunger, Visual analogue scale (VAS) for hunger (from minimum value = not hungry at all to maximum value = extremely hungry) before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours|Change in autonomic function, Change in heart-rate variability during a continuous ECG as indirect measure of measure of the autonomic function before and after a standardized meal after acute treatment or repeated treatment with anakinra or placebo. Repeated Treatment applies only to anakinra and to Group 2., 6 hours
Sponsor/Collaborators: Sponsor: University Hospital, Basel, Switzerland
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-01-13
Completion Date: 2024-05-28
Results First Posted:
Last Update Posted: 2025-01-29
Locations: University Hospital Basel, Basel, Basel BS, 4031, Switzerland
URL: https://clinicaltrials.gov/show/NCT04227769