SarcopeniaNCT05041348
Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.
An observational study of Sarcopenia, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- CT at the level of the third lumbar vertebra (L3)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2021to 17 Aug 2022
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with HBV-related liver cirrhosis were recruited between August 2021 and June 2022 at the Affiliated hospital of Qingdao University. All of the patients are in the decompensation stage of hepatitis B cirrhosis and divided them into two groups. One group is named cirrhosis with muscle mass loss, the other group is named liver cirrhosis with normal muscle mass. People in healthy control group were excluded metabolic diseases. Each group of patients is about 20.
Who may be able to join
- the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis B formulated according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis issued by the Chinese Society of Hepatology in 2019
- The diagnosis of muscle mass loss conforms to SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
- Patients aged between 18 and 60 years old
- Patients with no history of drinking or abstinence for more than 1 year
- Voluntary participants with informed consent
Who cannot join
- 1) the etiology of cirrhosis without hepatitis B virus (HBV), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without CT scan within 3 months; 8) patients who have exercise habits with the Physical Activity Rating Scale-3 (PARS-3) > 19 points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affiliated Hospital of Qingdao University
Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. Our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.
- Conditions
- Sarcopenia
- Being tested
- CT at the level of the third lumbar vertebra (L3)
- Keywords
- Hepatitis B virus-related liver cirrhosis, muscle mass loss, metabolites
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT at the level of the third lumbar vertebra (L3)Diagnostic test
Muscle mass loss was defined as an skeletal muscle mass index (SMI) less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
| Study group | Role | What they receive |
|---|---|---|
| liver cirrhosis patients with muscle mass loss | The diagnosis of cirrhosis was made based on the combination of clinical and laboratory features or by liver histopathology. Skeletal muscle mass index (SMI), which was the ratio of lean tissue area to body height. Muscle mass loss was defined as an SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females Receives: Diagnostic Test: CT at the level of the third lumbar vertebra (L3) | |
| liver cirrhosis patients with normal muscle mass | Skeletal muscle mass index (SMI) was not decreased in this group. Receives: Diagnostic Test: CT at the level of the third lumbar vertebra (L3) | |
| healthy group | People in healthy control group were excluded metabolic diseases (including diabetes, thyroid disorder, and so on) and other chronic diseases, according to their ultrasound and laboratory assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
amino acids metabolism
Arginine biosynthesis, Phenylalanine, tyrosine and tryptophan biosynthesis were the enrichment pathway in two groups.
Measured: 2021.09.01-2022.08.01
central carbon metabolism
D-fructose-6-phosphate,L-glutamic acid, and Fumaric acid were selected as differential metabolites in pathway of central carbon metabolism.
Measured: 2021.09.01-2022.08.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start17 Aug 2021
- Primary completion15 Jul 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041348
- Sponsor's protocol ID
- QYFYWZLL26461
- Status last verified
- Sep 2022
- First submitted
- 15 Jul 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affiliated Hospital of Qingdao University
- ClinicalTrials.gov ID
- NCT05041348
- Acronym / sponsor ID
- QYFYWZLL26461
- Conditions
- Sarcopenia
- Keywords
- Hepatitis B virus-related liver cirrhosis, muscle mass loss, metabolites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- 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.
Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. Our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| liver cirrhosis patients with muscle mass loss | – | Diagnostic Test: CT at the level of the third lumbar vertebra (L3)The diagnosis of cirrhosis was made based on the combination of clinical and laboratory features or by liver histopathology. Skeletal muscle mass index (SMI), which was the ratio of lean tissue area to body height. Muscle mass loss was defined as an SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females |
| liver cirrhosis patients with normal muscle mass | – | Diagnostic Test: CT at the level of the third lumbar vertebra (L3)Skeletal muscle mass index (SMI) was not decreased in this group. |
| healthy group | – | –People in healthy control group were excluded metabolic diseases (including diabetes, thyroid disorder, and so on) and other chronic diseases, according to their ultrasound and laboratory assessment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with HBV-related liver cirrhosis were recruited between August 2021 and June 2022 at the Affiliated hospital of Qingdao University. All of the patients are in the decompensation stage of hepatitis B cirrhosis and divided them into two groups. One group is named cirrhosis with muscle mass loss, the other group is named liver cirrhosis with normal muscle mass. People in healthy control group were excluded metabolic diseases. Each group of patients is about 20.
Key inclusion criteria (5 listed)
- the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis B formulated according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis issued by the Chinese Society of Hepatology in 2019
- The diagnosis of muscle mass loss conforms to SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
- Patients aged between 18 and 60 years old
- Patients with no history of drinking or abstinence for more than 1 year
- Voluntary participants with informed consent
Key exclusion criteria (1 listed)
- 1) the etiology of cirrhosis without hepatitis B virus (HBV), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without CT scan within 3 months; 8) patients who have exercise habits with the Physical Activity Rating Scale-3 (PARS-3) > 19 points
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 |
|---|---|---|
| CT at the level of the third lumbar vertebra (L3)Muscle mass loss was defined as an skeletal muscle mass index (SMI) less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females | Diagnostic test | liver cirrhosis patients with muscle mass loss, liver cirrhosis patients with normal muscle mass |
Primary outcome
amino acids metabolism
Time frame: 2021.09.01-2022.08.01
Arginine biosynthesis, Phenylalanine, tyrosine and tryptophan biosynthesis were the enrichment pathway in two groups.
central carbon metabolism
Time frame: 2021.09.01-2022.08.01
D-fructose-6-phosphate,L-glutamic acid, and Fumaric acid were selected as differential metabolites in pathway of central carbon metabolism.
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 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Sarcopenia, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 5 inclusion and 1 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 2022. 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 China. 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?
amino acids metabolism (time frame: 2021.09.01-2022.08.01). The study lists 2 primary outcomes in all. 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 2022.