MedTrace Logo

Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study

NCT02916355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-01-29

No results posted yet for this study

Summary

Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.

16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.

Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.

The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.

Conditions

  • Adiposity

Interventions

DRUG

Anakinra

Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.

DRUG

NaCl

subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Marc Y Donath, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-04-30
Completion
2017-04-03

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916355 on ClinicalTrials.gov