Peripheral Treg Cell Senescence & Serum Total Cholesterol Level

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680844
• Other study ID #: IRB2022-YX-244-01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Tianjin Medical University
• Contact: Xintong Ge, M.D.
• Phone: 60362237
• Email: xge[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age = 30 and = 60 years old with independent behavior ability.

2. 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:

1. Pregnant or lactating women.

2. 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).

3. 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.

4. Have participated in clinical trials in the past 3 months.

5. The investigator considers that not appropriate for inclusion.

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.