Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00931060|
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 15, 2009
|Condition or disease||Intervention/treatment||Phase|
|Liver Diseases Hepatic Encephalopathy Hepatic Insufficiency||Dietary Supplement: Branched chain amino acids||Not Applicable|
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|
|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|
U.S. FDA Resources
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
- arterial ammonia concentration [ Time Frame: 1 and 3 hours ]
- muscle ammonia metabolism [ Time Frame: 1 hour and 3 hours ]
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
|Study Chair:||Susanne Keiding, MD||PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital|