Local Effects of Amino Acids in the Bilaterally Perfused Human Leg
This trial is active, not recruiting.
|Conditions||critical illness, protein metabolism, pharmaconutrients|
|Treatments||vamin (fresenius kabi), 3hydroxybutyrate|
|Sponsor||University of Aarhus|
|Start date||September 2011|
|End date||February 2013|
|Trial size||10 participants|
|Trial identifier||NCT01461603, M-20110177|
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.
Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.
Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.
Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
Changes in muscle metabolism after administration of amino acids.
time frame: Basal period and a glucose clamp (6 hours pr.day)
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
time frame: Basal period and a glucose clamp (6 hours pr. day)
Male participants from 21 years up to 50 years old.
Inclusion Criteria: - BMI between 19 and 28 - Written consent before study start Exclusion Criteria: - Diabetes - Inclusion in other studies using ionizing radiation. - Allergic to egg or soy
|Official title||Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg|
|Principal investigator||Niels Møller, Professor, Dr.Med.|
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