Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00931060
First received: June 30, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.


Condition Intervention
Liver Diseases
Hepatic Encephalopathy
Hepatic Insufficiency
Dietary Supplement: Branched chain amino acids

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • arterial ammonia concentration [ Time Frame: 1 and 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle ammonia metabolism [ Time Frame: 1 hour and 3 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Branched chain amino acids
Patients with cirrhosis. Healthy subjects age and sex matched
Dietary Supplement: Branched chain amino acids
Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 patients with liver cirrhosis
  • 6 healthy subjects age and sex matched

Exclusion Criteria:

  • Non-treated diabetes
  • Pregnancy/breast-feeding
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00931060

Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Susanne Keiding, MD PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gitte Dam, PET Centre. Aarhus University Hospital.
ClinicalTrials.gov Identifier: NCT00931060     History of Changes
Other Study ID Numbers: 15580
Study First Received: June 30, 2009
Last Updated: September 14, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Ammonia
Citric acid cycle
Branched Chain Amino Acids

Additional relevant MeSH terms:
Hepatic Encephalopathy
Fibrosis
Liver Diseases
Hepatic Insufficiency
Liver Failure
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014