A New Model of Acute Febrile Disease

Fasting Clinical Trial

Official title:

A New Model of Acute Febrile Disease - Combining Endotoxemia, Immobilisation and Fasting in Healthy Young Males.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158363
• Other study ID #: TheValidationStudy
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: May 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to establish a new model of acute febrile disease by mimicking the conditions seen in hospitalized patients in regards to inflammation, immobilisation and fasting. In this new model of disease, healthy young adults will be given lipopolysaccharide (LPS) to induce endotoxemia and inflammation/fever and then fast and bedrest for 36 hours. Glucose, fat and protein metabolism will be investigated using clamp technique and tracer methodology together with intracellular signalling pathway activation in muscle and fat biopsies. This new model of disease will later be used in another study to investigate different protein supplement´s effect on muscle waste during acute febrile disease.

Description:

The investigators want to establish a new model of acute febrile disease by mimicking the conditions seen in hospitalized patients in regards to inflammation, immobilisation and fasting. In this new model of disease, healthy young adults will be given lipopolysaccharide (LPS) to induce endotoxemia and inflammation on study day 1 and then fast and bedrest for 36 hours (Study day 2). Glucose, fat and protein metabolism will be investigated using clamp technique and tracer methodology together with intracellular signalling pathway activation in muscle and fat biopsies. This new model of disease will later be used in another study to investigate different protein supplement´s effect on muscle waste during acute febrile disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male sex

• 20 < BMI < 30

• 20 < Age < 40 years

• Written consent prior to trial

Exclusion Criteria:

• Participation in trials using ionized radiation a year prior to this trial.

• Comprehensive x-ray examinations in the study period.

• In case of immobilization of an extremity, the extremity should be fully re- habilitated and this should be stated by a physician or physiotherapist. The test subject's word for this will be sufficient.

• Allergies to eggs or soy oil.

• Diseases: Diabetes, epilepsy, ongoing infectious disease, immunodeficiency, heart disease, dysregulated hypertension.

Related Conditions & MeSH terms

• Endotoxemia
• Fasting
• Immobilization, Tonic
• Metabolism

Intervention

Other:
• LPS, 36 hour immobilization and fast
LPS endotoxin is administered on study day 1 and immobilization and fast continue throughout study day 1 and 2.

Locations

Country	Name	City	State
Denmark	Institute for Clinical MEdicine	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Arla

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity	Measured by hyperinsulinemic euglycemic clamp technique	After a 3 hour clamp
Secondary	Protein metabolism	Quantified by phenylalanine and tyrosine tracer methodology (whole body and the forearm model)	measured at baseline and after 3 hours of clamp
Secondary	ketone body metabolic changes	measurement of ketone bodies	measured at baseline and after 3 hours of clamp
Secondary	inflammation	Quantified by C-reactive peptide (CRP), white blood cell count, cytokines	measurements over 36 hours
Secondary	Intracellular signalling pathway activation	Intracellular signalling pathway activation in muscle and fat	measured at baseline and after 3 hours of clamp
Secondary	Energy expenditure	measured by indirect calorimetry	measured at baseline and after 3 hours of clamp for 15 minutes
Secondary	Glucose metabolism	measured by glucose tracer, calculations of rate of appearance, disappearance and endogenous glucose production	measured at baseline and after 3 hours of clamp
Secondary	Hormonal changes	measures of insulin, glucagon, c-peptide and growth hormone	measured at baseline and after 3 hours of clamp
Secondary	CD163	measures of CD163 and soluble CD163 (sCD163) after LPS exposure	0, 24 and 48 hours after LPS exposure
Secondary	Fat metabolism	measured by palmitate tracer, calculating whole body palmitate flux. Measures of free fatty acids.	measured at baseline and after 3 hours of clamp
Secondary	Urea balance	measured by urea tracer and urine nitrogen excretion.	measured at baseline and after 3 hours of clamp
Secondary	Glucose uptake by the forearm	Arterio-venous balance x blodflow	measured at baseline and after 3 hours of clamp