Peripheral Treg Cell Senescence & Serum Total Cholesterol Level

Sponsor

Tianjin Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05680844

Collaborator

(none)

200

Enrollment

2.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia

Detailed Description

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Observational Study of the Correlation Between Peripheral Treg Cell Senescence and Serum Total Cholesterol Level

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
normal cholesterol level group Serum total cholesterol level of < 5.17 mmol/L
hypercholesterolemia group Serum total cholesterol level of >= 5.17 mmol/L

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
The investigator considers that not appropriate for inclusion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tianjin Medical University

Investigators

Principal Investigator: Xintong Ge, M.D., Tianjin Medical University General Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Xintong Ge, Professor, Tianjin Medical University General Hospital

ClinicalTrials.gov Identifier:

NCT05680844

Other Study ID Numbers:

IRB2022-YX-244-01

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xintong Ge, Professor, Tianjin Medical University General Hospital

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Jan 11, 2023