CirrhosisNCT02132962
Sarcopenia and Cirrhosis
A study testing Amino acid infusion and Bloodsamples, Biopsies. in people with Cirrhosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls. The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Amino acid infusion and Bloodsamples, Biopsies.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Oct 2015
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects
- Diagnosis of cirrhosis, Child-Pugh A, B, C.
Who cannot join
- Acute illness within 3 weeks
- Ascites collections within 10 days
- Heart-, kidney, pulmonary disease. Cancer. Type 1 diabetes.
- Active alkoholdrinking
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls.
The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.
- Conditions
- Cirrhosis
- Being tested
- Amino acid infusion, Bloodsamples, Biopsies.
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid infusionDietary supplement
Bloodsamples, Biopsies.Other
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Active comparator | Amino acid infusion Receives: Dietary Supplement: Amino acid infusion; Other: Bloodsamples, Biopsies. |
| Cirrhosis | Active comparator | Amino acid infusion Receives: Dietary Supplement: Amino acid infusion; Other: Bloodsamples, Biopsies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade.
Using stable isotope tracer technique with infusion of phenylalanine and tyrosine tracer.
Using ELISA technique. Using PCR and western blot technique.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132962
- Sponsor's protocol ID
- H-4-2012-162
- Status last verified
- Sep 2015
- First submitted
- 30 Apr 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Cirrhosis
- ClinicalTrials.gov ID
- NCT02132962
- Acronym / sponsor ID
- H-4-2012-162
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- First posted
- 7 May 2014 (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 study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls.
The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Active comparator | Dietary Supplement: Amino acid infusion, Other: Bloodsamples, Biopsies.Amino acid infusion |
| Cirrhosis | Active comparator | Dietary Supplement: Amino acid infusion, Other: Bloodsamples, Biopsies.Amino acid infusion |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male subjects
- Diagnosis of cirrhosis, Child-Pugh A, B, C.
Key exclusion criteria (4 listed)
- Acute illness within 3 weeks
- Ascites collections within 10 days
- Heart-, kidney, pulmonary disease. Cancer. Type 1 diabetes.
- Active alkoholdrinking
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 |
|---|---|---|
| Amino acid infusion | Dietary supplement | Cirrhosis, Healthy controls |
| Bloodsamples, Biopsies. | Other | Cirrhosis, Healthy controls |
Primary outcome
Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade.
Time frame: 24 weeks
Using stable isotope tracer technique with infusion of phenylalanine and tyrosine tracer. Using ELISA technique. Using PCR and western blot technique.
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 29 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid infusion and Bloodsamples, Biopsies. in people with Cirrhosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade. (time frame: 24 weeks). 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 29 Oct 2015.