Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
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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 |
- arterial ammonia concentration [ Time Frame: 1 and 3 hours ] [ Designated as safety issue: No ]
- 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 |
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 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 May 16, 2013