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

NCT ID: NCT00931060

Last Updated: 2009-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Diseases Hepatic Encephalopathy Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Branched chain amino acids

Patients with cirrhosis. Healthy subjects age and sex matched

Group Type EXPERIMENTAL

Branched chain amino acids

Intervention Type DIETARY_SUPPLEMENT

Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day

Interventions

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Branched chain amino acids

Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-treated diabetes
* Pregnancy/breast-feeding
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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PET Centre. Aarhus University Hospital.

Principal Investigators

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Susanne Keiding, MD

Role: STUDY_CHAIR

PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital

Other Identifiers

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15580

Identifier Type: -

Identifier Source: org_study_id

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