CirrhosisNCT06328517
The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models
An observational study of Cirrhosis, run by Juan Kang at 1 site in China.
Trial summary
Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa.
Who may be able to join
- Willing and able to sign an informed consent form;
- Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa;
- Estimated survival time of more than 3 months;
- Full capacity for civil conduct.
Who cannot join
- The diagnosis of primary liver cancer or was supported by the following evidence: increased alpha-fetoprotein (AFP) (≥100 μg/L) for more than 3 months or liver imaging showed clear liver cancer nodules in the liver;
- A history of malignancy within 5 years prior to screening, except for specific cancers (such as basal cell skin cancer); current or prior history of major disease that may interfere with personal treatment, assessment or compliance. Major diseases are 25 major diseases as stipulated by the China Insurance Regulatory Commission;
- Severe lung disease, severe heart disease, diabetes mellitus, or genetic and metabolic diseases;
- Psychiatric hospitalization, attempted suicide, and / or temporary disability due to mental illness in the past five years;
- Pregnant or lactating women;
- The investigator considered not unsuitable for participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
juan Kang, +8613996112052, 68368892@qq.com
About this study
Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.
Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis.
Read the detailed description
Patients with Cirrhosis attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. The data to be collected include basic information including gender, age, height and weight; blood routine, liver and kidney function, coagulation function, abdominal CT / MRI, underlying disease, complications, treatment options, disease changes, etc; professional Resting Energy Expenditure (REE) measurement and regular follow-up. After the data collection, the effects of REE, albumin, 2,5-OH vitamin D, and muscle function on the long-term prognosis of the patients with Cirrhosis were investigated by drawing the survival curve, the Receiver-Operating Characteristic curve (ROC curve) , and the Area Under a ROC curve (AUC curve) .
- Conditions
- Cirrhosis
- Keywords
- rest energy expenditure, malnutrition, prognosis
- Medical subject headings
- Fibrosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cirrhosis | Abdominal ultrasound, CT, or MRI showed Cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death due to cirrhosis progression
Measured: January 2024 to November 2026
Secondary outcomes (1)
complication
complication such as infection, ascites.
Measured: January 2024 to November 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Juan Kang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Kang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- juan Kang, M.D., Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328517
- Sponsor's protocol ID
- 2023-305
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models
- ClinicalTrials.gov ID
- NCT06328517
- Acronym / sponsor ID
- 2023-305
- Conditions
- Cirrhosis
- Keywords
- rest energy expenditure, malnutrition, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Juan KangUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.
Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis.
Detailed description
Patients with Cirrhosis attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. The data to be collected include basic information including gender, age, height and weight; blood routine, liver and kidney function, coagulation function, abdominal CT / MRI, underlying disease, complications, treatment options, disease changes, etc; professional Resting Energy Expenditure (REE) measurement and regular follow-up. After the data collection, the effects of REE, albumin, 2,5-OH vitamin D, and muscle function on the long-term prognosis of the patients with Cirrhosis were investigated by drawing the survival curve, the Receiver-Operating Characteristic curve (ROC curve) , and the Area Under a ROC curve (AUC curve) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cirrhosis | – | –Abdominal ultrasound, CT, or MRI showed Cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa.
Key inclusion criteria (4 listed)
- Willing and able to sign an informed consent form;
- Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were> 17.5kPa;
- Estimated survival time of more than 3 months;
- Full capacity for civil conduct.
Key exclusion criteria (6 listed)
- The diagnosis of primary liver cancer or was supported by the following evidence: increased alpha-fetoprotein (AFP) (≥100 μg/L) for more than 3 months or liver imaging showed clear liver cancer nodules in the liver;
- A history of malignancy within 5 years prior to screening, except for specific cancers (such as basal cell skin cancer); current or prior history of major disease that may interfere with personal treatment, assessment or compliance. Major diseases are 25 major diseases as stipulated by the China Insurance Regulatory Commission;
- Severe lung disease, severe heart disease, diabetes mellitus, or genetic and metabolic diseases;
- Psychiatric hospitalization, attempted suicide, and / or temporary disability due to mental illness in the past five years;
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: January 2024 to November 2026
Death due to cirrhosis progression
1 secondary outcome
complication
Time frame: January 2024 to November 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
juan Kang, M.D. study chair
The Second Affiliated Hospital of Chongqing Medical University
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 Cirrhosis, run by Juan Kang 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact juan Kang, M.D. (8613996112052, 68368892@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: January 2024 to November 2026). 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 25 Jun 2025.