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

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00931060
• Collaborator: (none)
• Enrollment: 24
• Arm: 1
• Duration (Months): 19

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. arterial ammonia concentration [1 and 3 hours]

Secondary Outcome Measures

1. muscle ammonia metabolism [1 hour and 3 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• University of Aarhus

Investigators

• Study Chair: Susanne Keiding, MD, PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00931060
• Other Study ID Numbers: 15580
• First Posted: Jul 2, 2009
• Last Update Posted: Sep 15, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Ammonia; Citric acid cycle; Branched Chain Amino Acids
• Additional relevant MeSH terms: Liver Diseases; Hepatic Encephalopathy; Hepatic Insufficiency; Liver Failure; Brain Diseases

Study Results

No Results Posted as of Sep 15, 2009