ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00931060
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Liver Diseases Hepatic Encephalopathy Hepatic Insufficiency Dietary Supplement: Branched chain amino acids Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Study Start Date : November 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. arterial ammonia concentration [ Time Frame: 1 and 3 hours ]

Secondary Outcome Measures :
  1. muscle ammonia metabolism [ Time Frame: 1 hour and 3 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931060


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

Additional Information:
Responsible Party: Gitte Dam, PET Centre. Aarhus University Hospital.
ClinicalTrials.gov Identifier: NCT00931060     History of Changes
Other Study ID Numbers: 15580
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

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

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