Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04223557
Eligibility Criteria:
Inclusion Criteria:
1. Males and Females aged 18-70 years old.
2. Each side of caudal perirenal fat volume \>8000mm3（measured by ultrasound).
3. Low and medium-risk of arteriosclerotic cardiovascular disease (ASCVD) with 3.4 ≤ LDL-C \< 4.9 mmol/L or 5.2 ≤ TC \< 7.2 mmol/L, as defined by the Chinese guidelines for the management of dyslipidemia in adults(revised edition 2016).
4. Participants should be willing to sign the informed consent form of the study.
Exclusion Criteria:
1. Familial hyperlipidemia.
2. Participants are taking cholesterol metabolism related drugs (e.g. fibrate drugs, thiazide diuretics, glucocorticoid, para-amino salicylic acid, colchicine, thyroid hormone, thyroid preparation, hypoglycemic, heparin, new oral anticoagulant, chlortetracycline, kanamycin, neomycin).
3. Participants are unwilling to stop taking statins.
4. Presence of history of hypertension and at least 2 of the following risk factors:
* History of smoking (more than 10 years and more than 10 cigarettes per day).
* Male ≥ 45 years old, female ≥ 55 years old.
* HDL-C≤1 mmol/L.
5. Presence of clinical documented atherosclerotic cardiovascular diseases (including acute coronary syndrome, stable angina, coronary revascularization, ischemic cardiomyopathy, stroke, transient cerebral ischemia and peripheral atherosclerosis disease defined as stenosis ≥50% or complex plaques of lower limb arteries, renal arteries, carotid arteries and other peripheral arteries).
6. Presence of cardiovascular diseases(e.g. all types of atrial fibrillation; severe structural heart disease including severe pulmonary hypertension resulting from severe aortic or ventricular septal defect, complicated anomaly and severe valvular disease; second degree or above heart block).
7. Presence of previous surgery of kidney or pararenal tissue.
8. Presence of endocrine-related diseases(e.g. Diabetes, Cushing syndrome, thyroidectomy or thyroid dysfunction in need of drug treatment, primary aldosteronism, Hypofunction of adrenal cortex, Polycystic Ovary Syndrome, Hyperparathyroidism, Insulin tumor, Zollinger-Ellison syndrome).
9. Presence of autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, Sjögren syndrome, scleroderma, ulcerative colitis, dermatomyositis, pemphigus, mixed connective tissue disease, sarcoidosis, Takayasu Arteritis).
10. Presence of severe hematologic diseases (e.g. leukemia, lymphoma, aplastic anemia, autoimmune hemolytic anemia, multiple myeloma, Primary Immune Thrombocytopenia, thrombotic thrombocytopenic Purpura, abnormal coagulation).
11. Presence of infectious diseases (e.g. Hepatitis, tuberculosis, AIDS, syphilis, malaria, measles).
12. Presence of parasitic diseases.
13. Presence of significant liver dysfunction (ALT or AST elevation greater than 2 times normal upper limit or other evidence of liver injury).
14. Presence of significant renal dysfunction (GFR\< 90 mL / min / 1.73 m2 or other evidence of renal injury).
15. Presence of urinary calculi and/or hematuria (gross hematuria or occult blood positive).
16. Presence of skin infection at the waist.
17. Presence of active malignancy.
18. Pregnant women or in suckling period or planning for pregnancy in trial period.
19. Participants are unwilling to sign an informed consent form.
20. Participants are unable or unwilling to complete follow-up evaluations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04223557
Study Brief:
Protocol Section:
NCT04223557