IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- Inflammation
- Metabolic Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Investigator)Masking Description: Randomized, double-blinded and open-label, placebo-controlled, partly cross-over clinical trialPrimary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 insul...
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.
Tracking Information
- NCT #
- NCT04227769
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marc Y Donath, Prof. Dr. MD University Hospital, Basel, Switzerland
Get Well Soon