NCT05680844

Brief Summary

Hypercholesterolemia is a risk factor for the occurrence and development of atherosclerosis. Recent animal studies have found that increased serum cholesterol level is associated with peripheral Treg cell senescence, but clinical evidence is still lacking. The purpose of this study is to analyze the correlation between human peripheral Treg cell senescence and serum total cholesterol level using clinical blood samples, thus laying a foundation for the establishment of novel therapeutic strategies for atherosclerosis based on the regulation of Treg cell senescence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

December 23, 2022

Last Update Submit

April 7, 2025

Conditions

Keywords

Tregcell senescencehypercholesterolemiatotal cholesterol

Outcome Measures

Primary Outcomes (1)

  • Treg cell senescence

    Treg cell senescence will be evaluated by the beta-galactosidase (SA-betagal) activity test

    After confirming the subject has signed the informed consent, and recorded the past medical history and medication (especially hypolipidemic drugs) in the past 3 months.

Study Arms (2)

normal cholesterol level group

Serum total cholesterol level of \< 5.17 mmol/L

hypercholesterolemia group

Serum total cholesterol level of \>= 5.17 mmol/L

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 200 subjects were randomly selected from the population receiving physical examination in the Cadre Physical examination Center of Tianjin Medical University General Hospital from January 2023 to March 2023.

You may qualify if:

  • Age ≥ 30 and ≤ 60 years old with independent behavior ability.
  • The participants need to fully understand the purpose and content of the study, and voluntarily participate in the study and sign the informed consent.

You may not qualify if:

  • Pregnant or lactating women.
  • Acute and severe diseases in the last 3 months, including but not limited to, acute myocardial infarction, acute cerebral infarction, cerebral hemorrhage, circulatory failure, respiratory failure (internal diseases), trauma requiring hospitalization, or undergoes surgery under general anesthesia (surgical diseases).
  • History of severe diseases, including but not limited to, tumors, serious hematological diseases, serious cardiopulmonary diseases (interventional therapy for coronary artery disease, atrial fibrillation, chronic obstructive pulmonary disease, etc.), renal failure, liver failure, old stroke with serious sequelae.
  • Have participated in clinical trials in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ping Lei, Ph.D.

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 11, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations