Liver DiseasesNCT00931060
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
A study testing Branched chain amino acids in people with Liver Diseases and Hepatic Encephalopathy, run by University of Aarhus.
Trial summary
The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Hepatic Encephalopathy, Hepatic Insufficiency
- What is being tested?
- Branched chain amino acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 patients with liver cirrhosis
- 6 healthy subjects age and sex matched
Who cannot join
- Non-treated diabetes
- Pregnancy/breast-feeding
About this study
The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.
Read the 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.
- Being tested
- Branched chain amino acids
- Keywords
- Ammonia, Citric acid cycle, Branched Chain Amino Acids
- Medical subject headings
- Liver Diseases, Hepatic Encephalopathy, Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched chain amino acidsDietary supplement
Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day
| Study group | Role | What they receive |
|---|---|---|
| Branched chain amino acids | Experimental | Patients with cirrhosis. Healthy subjects age and sex matched Receives: Dietary Supplement: Branched chain amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial ammonia concentration
Measured: 1 and 3 hours
Secondary outcomes (1)
muscle ammonia metabolism
Measured: 1 hour and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Keiding, MD, Study chair, PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931060
- Sponsor's protocol ID
- 15580
- Status last verified
- Sep 2009
- First submitted
- 30 Jun 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00931060
- Acronym / sponsor ID
- 15580
- Keywords
- Ammonia, Citric acid cycle, Branched Chain Amino Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Branched chain amino acids | Experimental | Dietary Supplement: Branched chain amino acidsPatients with cirrhosis. Healthy subjects age and sex matched |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 patients with liver cirrhosis
- 6 healthy subjects age and sex matched
Key exclusion criteria (2 listed)
- Non-treated diabetes
- Pregnancy/breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched chain amino acidsBranched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day | Dietary supplement | Branched chain amino acids |
Primary outcome
arterial ammonia concentration
Time frame: 1 and 3 hours
1 secondary outcome
muscle ammonia metabolism
Time frame: 1 hour and 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Keiding, MD study chair
PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Branched chain amino acids in people with Liver Diseases and Hepatic Encephalopathy, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial ammonia concentration (time frame: 1 and 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.