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Peripheral Treg Cell Senescence & Serum Total Cholesterol Level

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05680844
Recruitment Status : Recruiting
First Posted : January 11, 2023
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
Xintong Ge, Tianjin Medical University General Hospital

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
Hypercholesterolemia

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Observational Study of the Correlation Between Peripheral Treg Cell Senescence and Serum Total Cholesterol Level
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
normal cholesterol level group
Serum total cholesterol level of < 5.17 mmol/L
hypercholesterolemia group
Serum total cholesterol level of >= 5.17 mmol/L



Primary Outcome Measures :
  1. Treg cell senescence [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05680844


Contacts
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Contact: Xintong Ge, M.D. 60362237 xge@tmu.edu.cn

Locations
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China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Xintong Ge, M.D.         
Sponsors and Collaborators
Tianjin Medical University
Investigators
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Principal Investigator: Ping Lei, Ph.D. Tianjin Medical University General Hospital
  Study Documents (Full-Text)

Documents provided by Xintong Ge, Tianjin Medical University General Hospital:
Study Protocol  [PDF] December 1, 2022
Informed Consent Form  [PDF] December 1, 2022

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Responsible Party: Xintong Ge, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT05680844    
Other Study ID Numbers: IRB2022-YX-244-01
First Posted: January 11, 2023    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xintong Ge, Tianjin Medical University General Hospital:
Treg
cell senescence
hypercholesterolemia
total cholesterol
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases