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NCT Number: NCT03158363

A New Model of Acute Febrile Disease

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.

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Key information

Conditions

Immobilization, Tonic Bacteremia Behavior Behavior, Animal Endotoxemia Fasting Feeding Behavior Immobility Response, Tonic Infections Inflammation Metabolism Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical MEdicine

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LPS, 36 hour immobilization and fast

Other

LPS endotoxin is administered on study day 1 and immobilization and fast continue throughout study day 1 and 2.

Primary outcomes

  1. insulin sensitivity

    Time frame: After a 3 hour clamp

    Measured by hyperinsulinemic euglycemic clamp technique

Secondary outcomes

  1. Protein metabolism

    Time frame: measured at baseline and after 3 hours of clamp

    Quantified by phenylalanine and tyrosine tracer methodology (whole body and the forearm model)

  2. ketone body metabolic changes

    Time frame: measured at baseline and after 3 hours of clamp

    measurement of ketone bodies

  3. inflammation

    Time frame: measurements over 36 hours

    Quantified by C-reactive peptide (CRP), white blood cell count, cytokines

  4. Intracellular signalling pathway activation

    Time frame: measured at baseline and after 3 hours of clamp

    Intracellular signalling pathway activation in muscle and fat

  5. Energy expenditure

    Time frame: measured at baseline and after 3 hours of clamp for 15 minutes

    measured by indirect calorimetry

  6. Glucose metabolism

    Time frame: measured at baseline and after 3 hours of clamp

    measured by glucose tracer, calculations of rate of appearance, disappearance and endogenous glucose production

  7. Hormonal changes

    Time frame: measured at baseline and after 3 hours of clamp

    measures of insulin, glucagon, c-peptide and growth hormone

  8. CD163

    Time frame: 0, 24 and 48 hours after LPS exposure

    measures of CD163 and soluble CD163 (sCD163) after LPS exposure

  9. Fat metabolism

    Time frame: measured at baseline and after 3 hours of clamp

    measured by palmitate tracer, calculating whole body palmitate flux. Measures of free fatty acids.

  10. Urea balance

    Time frame: measured at baseline and after 3 hours of clamp

    measured by urea tracer and urine nitrogen excretion.

  11. Glucose uptake by the forearm

    Time frame: measured at baseline and after 3 hours of clamp

    Arterio-venous balance x blodflow

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Arla Foods

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 18, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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