Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Diseases; Hepatic Encephalopathy; Hepatic Insufficiency
Intervention: Branched chain amino acids (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Susanne Keiding, MD, Study Chair, Affiliation: PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
Summary
The purpose of this study is to determine whether Branched chain Amino Acids enhances the
uptake of ammonia in muscle tissue.
Clinical Details
Official title: Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: arterial ammonia concentration
Secondary outcome: muscle ammonia metabolism
Detailed description:
Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic
encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in
muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion
of alfa-ketoglutarate to ammonia via glutamine.
We intend to study the effect of oral administered BCAA on the metabolism of ammonia and
amino acids across the leg-muscles by means of catheters inserted into the femoral artery
(A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of
indocyanine green and indicator dilution principle. Arterial blood flow and A and V
concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0. 45
g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be
estimated by means of 13N-NH3 PET scans.
Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial
ammonia.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 patients with liver cirrhosis
- 6 healthy subjects age and sex matched
Exclusion Criteria:
- Non-treated diabetes
- Pregnancy/breast-feeding
Locations and Contacts
Additional Information
Starting date: November 2007
Last updated: September 14, 2009
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