A Cholesterol Lowering Therapy of Focused Power Ultrasound Mediated Perirenal Fat Ablation

NCT04223557 | Completed DMC

• 1 other identifier: 2019-SR-388
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about focused power ultrasound (FPU)-mediated perirenal fat (PRF) ablation for lowering serum cholesterol levels. The main questions it aims to answer are: What is the efficacy, safety, and tolerability of focused power ultrasound (FPU)-mediated perirenal fat ablation for lowering low-density lipoprotein cholesterol (LDL-C) levels? Participants will randomly receive PRF ablation or sham treatment, and undergo follow-up at 24 hours, 1 month, and 3 months post-procedure.

Conditions

Visceral Obesity; Ultrasound Therapy; Dyslipidemias

Keywords

Perirenal fat; Ultrasound Therapy; Dyslipidemias; low-density lipoprotein cholesterol

Outcome Measures

Primary Outcomes (2)

• The difference in low-density lipoprotein cholesterol (LDL-C) levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure

  The difference in LDL-C levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure.

  Day 0 (baseline) to 3-month (end of follow-up)

• Incidence of all-cause deaths and serious adverse events

  Serious adverse events including acute liver failure, acute renal failure, acute intestinal perforation, severe embolic events and etc.

  Day 0 (baseline) to 3-month (end of follow-up)

Secondary Outcomes (2)

• The differences between the groups in blood lipid profiles (total cholesterol(TC), triglycerides(TG), and high-density lipoprotein cholesterol(HDL-C)) from baseline to 3 months post-procedure.

  Day 0 (baseline) to 3-month (end of follow-up)

• Incidence of other adverse events

  Day 0 (baseline) to 3-month (end of follow-up)

Study Arms (2)

FPU treatment

EXPERIMENTAL

Transcutaneous non-invasive ultrasound will be administered to the peri-renal fat for one time via a focused power ultrasound system (FPU) device.

Device: focused power ultrasound treatment

Sham treatment

SHAM COMPARATOR

Partcipates will receive the same procedure as those in experimental arm except that the device will not be activated.

Device: Sham treatment

Interventions

focused power ultrasound treatment DEVICE

Patients will be placed in the lateral decubitus position and receive treatment with sequential bilateral PRF ablation. Before the treatment, a professional sonographer will be responsible for the length, thickness, and width of PRF sac measurement and localisation, and utilise the ultrasonic diagnostic transducer to delineate the targeted region. The treatment will launch layer-by-layer. After confirming accurate localization of the treatment, layer-by-layer PRF ablation will be performed on the patients. The device generates and delivers a pattern of conic-shaped ultrasound energy to the PRF sac noninvasively. The treatment of FPU-mediated PRF ablation will be implemented once.

FPU treatment

Sham treatment DEVICE

Participants will receive the same procedure as those in the FPU treatment including PRF ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the PRF.

Sham treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females aged 18-70 years old.
• Each side of caudal perirenal fat volume \>8000mm3（measured by ultrasound).
• 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).
• Participants should be willing to sign the informed consent form of the study.

You may not qualify if:

• Familial hyperlipidemia.
• 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).
• Participants are unwilling to stop taking statins.
• 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.
• 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).
• 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).
• Presence of previous surgery of kidney or pararenal tissue.
• 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).
• 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).
• Presence of severe hematologic diseases (e.g. leukemia, lymphoma, aplastic anemia, autoimmune hemolytic anemia, multiple myeloma, Primary Immune Thrombocytopenia, thrombotic thrombocytopenic Purpura, abnormal coagulation).
• Presence of infectious diseases (e.g. Hepatitis, tuberculosis, AIDS, syphilis, malaria, measles).
• Presence of parasitic diseases.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Obesity, Abdominal; Dyslipidemias

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Xiangqing Kong, M.D.&PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology,Director,Clinical Professor,Principal Investigator

Model Details: This is a randomized, double-blinded, sham-controlled study.The ratio of the treatment group versus sham-control group was 2:1.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 10, 2020
• Study Start: May 30, 2020
• Primary Completion: July 8, 2021
• Study Completion: December 31, 2021
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)