NCT06591897

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
16mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Sep 2024Sep 2027

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 8, 2024

Last Update Submit

October 6, 2024

Conditions

Keywords

hepatocyteliver functionsex differences

Outcome Measures

Primary Outcomes (1)

  • 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.

    2027.08

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Liver function indicators are in the normal reference range.
  • Liver imaging examination showed normal.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, No.88 Jiefang Road, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue of segment IV ( about 1mm³ )

Study Officials

  • daren Liu, MD, PhD

    Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

daren Liu, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

September 27, 2024

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations