Healthy PopulationNCT06591897
Exploration of Gender Differences in Liver Aging
An observational study of Healthy Population, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The liver is an important metabolic organ in the body. It participates in central metabolic activities to maintain systemic homeostasis. It is also one of the most vulnerable organs in the process of individual aging. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 20 Sep 2027
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study, the normal liver sampling criteria are as follows : 1.Preoperative blood biochemical liver function indicators are in the normal reference range. 2.Liver imaging is normal. The liver is normal in size, regular in shape, smooth in capsule, uniform in parenchymal echo, and intrahepatic vascular network. For patients undergoing laparoscopic cholecystectomy, the liver tissue of the IV segment of the liver ( about 1mm3 ) was separated from the gallbladder wall specimen.
Who may be able to join
- Liver function indicators are in the normal reference range.
- Liver imaging examination showed normal.
Who cannot join
- Patients with previous liver-related diseases.
- Subjects with important organ dysfunction / failure or other serious diseases ( myocardial infarction, malignant tumor, severe neurological or psychiatric history, severe infection, coagulation dysfunction, etc. )
- Moderate malnutrition ( BMI < 17kg / m2 ) and severe anemia ( Hb < 60g / L ).
- Subjects and their families who disagreed with the study protocol.
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
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, No.88 Jiefang Road
Liu Daren, MD, PhD, +86-15968179036, darenliu@zju.edu.cn
About this study
The liver is an important metabolic organ in the body. It participates in central metabolic activities to maintain systemic homeostasis. It is also one of the most vulnerable organs in the process of individual aging. During aging, the volume, blood flow, metabolic capacity and regenerative capacity of the liver decrease. Liver function changes with age can lead to age-related systemic susceptibility diseases.
Therefore, understanding the changes of metabolism and immune function in the process of liver aging and studying the regulation mechanism of liver aging will provide an important reference for understanding the causes of increased susceptibility to liver-related diseases in the elderly population.On the other hand, gender factors also affect organ function, leading to differences in human aging and disease outcomes.At present, the omics research on liver aging is mainly based on tissue-level transcription, protein or metabolomics, and most of the conclusions are focused on hepatocytes. However, for other cell types and microenvironment interactions, people know little about the aging changes at the cellular levelBased on the current research status, this study aims to explore the gender differences in the process of liver aging, using emerging technologies such as the combination of single-cell multi-omics and spatial localization, to reveal the factors driving liver aging from a gender perspective, and to promote the development of accurate interventions for aging and aging-related diseases.
- Conditions
- Healthy Population
- Keywords
- hepatocyte, liver function, sex differences
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular and cellular characteristics during liver aging
Draw the map information of liver aging single cell precision, and clarify whether the effect of aging on liver cell types has gender differences.
Measured: 2027.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 only
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- daren Liu, MD, PhD, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591897
- Sponsor's protocol ID
- 2024-0815
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Gender Differences in Liver Aging
- ClinicalTrials.gov ID
- NCT06591897
- Acronym / sponsor ID
- 2024-0815
- Conditions
- Healthy Population
- Keywords
- hepatocyte, liver function, sex differences
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 19 Sep 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.
The liver is an important metabolic organ in the body. It participates in central metabolic activities to maintain systemic homeostasis. It is also one of the most vulnerable organs in the process of individual aging. During aging, the volume, blood flow, metabolic capacity and regenerative capacity of the liver decrease. Liver function changes with age can lead to age-related systemic susceptibility diseases.
Therefore, understanding the changes of metabolism and immune function in the process of liver aging and studying the regulation mechanism of liver aging will provide an important reference for understanding the causes of increased susceptibility to liver-related diseases in the elderly population.On the other hand, gender factors also affect organ function, leading to differences in human aging and disease outcomes.At present, the omics research on liver aging is mainly based on tissue-level transcription, protein or metabolomics, and most of the conclusions are focused on hepatocytes. However, for other cell types and microenvironment interactions, people know little about the aging changes at the cellular levelBased on the current research status, this study aims to explore the gender differences in the process of liver aging, using emerging technologies such as the combination of single-cell multi-omics and spatial localization, to reveal the factors driving liver aging from a gender perspective, and to promote the development of accurate interventions for aging and aging-related diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, the normal liver sampling criteria are as follows : 1.Preoperative blood biochemical liver function indicators are in the normal reference range. 2.Liver imaging is normal. The liver is normal in size, regular in shape, smooth in capsule, uniform in parenchymal echo, and intrahepatic vascular network. For patients undergoing laparoscopic cholecystectomy, the liver tissue of the IV segment of the liver ( about 1mm3 ) was separated from the gallbladder wall specimen.
Key inclusion criteria (2 listed)
- Liver function indicators are in the normal reference range.
- Liver imaging examination showed normal.
Key exclusion criteria (4 listed)
- Patients with previous liver-related diseases.
- Subjects with important organ dysfunction / failure or other serious diseases ( myocardial infarction, malignant tumor, severe neurological or psychiatric history, severe infection, coagulation dysfunction, etc. )
- Moderate malnutrition ( BMI < 17kg / m2 ) and severe anemia ( Hb < 60g / L ).
- Subjects and their families who disagreed with the study protocol.
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
Molecular and cellular characteristics during liver aging
Time frame: 2027.08
Draw the map information of liver aging single cell precision, and clarify whether the effect of aging on liver cell types has gender differences.
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 8 Oct 2024.
- 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.
daren Liu, MD, PhD study director
Zhejiang 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 Healthy Population, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. 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 daren Liu, MD, PhD (15968179036, darenliu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular and cellular characteristics during liver aging (time frame: 2027.08). 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 8 Oct 2024.