Non-alcoholic Fatty Liver DiseaseNCT06225713
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease (PARADISE-NAFLD)
A study testing focused power ultrasound mediated inferior perirenal adipose tissue modification in people with Non-alcoholic Fatty Liver Disease, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
Trial summary
This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- focused power ultrasound mediated inferior perirenal adipose tissue modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 2 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older at the time of screening.
- Total liver fat content ≥10% measured by MRI-PDFF.
- Body mass index (BMI) ≥ 25 kg/m^2.
- The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm.
- Participants should be willing to sign the informed consent form of the study.
Who cannot join
- History of significant alcohol consumption (significant alcohol consumption was defined as more than 140 g/week in females and more than 210 g/week in males in the last 12months before screening, on average).
- Secondary factors causing hepatic steatosis, including viral hepatitis C, autoimmune hepatitis, total parenteral nutrition, celiac disease, Wilson's disease, hypothyroidism, hereditary hemochromatosis, drug factors (amiodarone, glucocorticoids, methotrexate, tamoxifen), etc.
- Complicating other chronic liver diseases, mainly including viral hepatitis, cholestatic liver disease, drug-induced liver injury, etc.
- Weight change >10% in the past 3 months.
- Clinical or pathological diagnosis of cirrhosis.
- NAFLD treatment drugs (such as vitamin E, obecholic acid, thiazolidinediones, etc.) were used within 6 months before enrollment.
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- History of bariatric surgery.
- History of kidney and/or surrounding tissue surgery.
- Waist skin infection.
- Urinary stones and/or hematuria (positive for gross hematuria or occult blood).
- Unstable cardiovascular diseases: (1) Myocardial infarction, unstable angina pectoris or cerebrovascular accident occurred in the last 6 months. (2) Persistent atrial fibrillation without anticoagulation. (3) Severe structural heart disease (including valvular heart disease, cardiomyopathy). (4) second degree and above atrioventricular block and/or sick sinus syndrome. (5) Uncontrolled hypertension.
- Type 1 diabetes or uncontrolled hyperglycemia (HBA1c ≥ 9.5%).
- Participants with untreated tumors.
- Laboratory screening results include one or more of the following: (1) Neutrophil absolute value <1.0x10^9/L. (2) Platelet count <100x10^9/L. (3) Hemoglobin <100g/L. (4) Albumin <35g/L. (5) International standard value >1.5. (6) Total bilirubin >1.5 times the upper limit of normal value. (7) The estimated glomerular filtration rate was <60ml/ (minx1.73m^2).
- Participants who are pregnant, breastfeeding or trying to conceive.
- Any contraindication or inability to obtain an MRI.
- Participants who were unable to follow up.
- Any other situation that the investigator considers to be detrimental to the patient's health, hindering the completion of the study, or interfering with the results of the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qibin He
- Recruiting
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiangqing Kong, +8613951610265, kongxq@njmu.edu.cn
Xiangqing Kong
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Yanhui Sheng
About this study
Official title: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease: a Randomized Controlled Trial (PARADISE-NAFLD)
This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease.
Read the detailed description
Visceral adiposity is closely related to the incidence of non-alcoholic fatty liver disease (NAFLD), and it is also directly associated with liver inflammation and fibrosis. Visceral adiposity, via its unique location and enhanced lipolytic activity, releases toxic free fatty acids, which are delivered in high concentrations directly to the liver and lead to the accumulation and storage of hepatic fat. Furthermore, it has been recognized as an important endocrine organ, and a variety of factors secreted by visceral adiposity may lead to an increased risk of NAFLD.
Peri-renal fat is a special type of visceral adiposity which is different from other type of visceral fat in histology, physiology, and functions. The position of peri-renal fat is more stable than other visceral fat. The investigators found that prophylactic perirenal adipose tissue ablation can prevent the development of NAFLD in mice induced by high fat diets, and also this novel focused power ultrasound can rapidly and efficiently promote the peri-renal adipose tissue fibrosis in the model of swine. Moreover, the investigators performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior peri-renal adipose tissue in NAFLD participants, showing that this kind of method was feasible and safe.
In this study, the investigators aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for NAFLD.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- focused power ultrasound mediated inferior perirenal adipose tissue modification, sham-control group
- Keywords
- Non-alcoholic Fatty Liver Disease, Focused ultrasound, Novel method
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused power ultrasound mediated inferior perirenal adipose tissue modificationDevice
This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.
sham-control groupDevice
Participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting and initiating) Receives: Device: focused power ultrasound mediated inferior perirenal adipose tissue modification |
| sham-control group | Sham comparator | In sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment. Receives: Device: sham-control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Liver Fat Content
Absolute change in liver fat content assessed by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) at 3-month compared with baseline
Measured: From baseline to 3 months post-procedure
Secondary outcomes (6)
Relative Change in Liver Fat Content
Relative change in liver fat content assessed by MRI-PDFF at 3-month compared with baseline
Measured: From baseline to 3 months post-procedure
Proportion of MRI-PDFF Responders
Proportion of MRI-PDFF responders in two groups at 3-month of treatment. MRI-PDFF responder is defined as a ≥30% relative reduction in MRI-PDFF between baseline and end of treatment
Measured: From baseline to 3 months post-procedure
Change in Alanine Aminotransferase (ALT)
ALT is increased with liver damage. The blood levels of ALT are used to detect liver injury.
Measured: From baseline to 3 months post-procedure
Change in Concentration of Cytokeratin-18
Change in concentration of cytokeratin-18 in two groups at 3-month of treatment
Measured: From baseline to 3 months post-procedure
Change in Liver Stiffness Measurement and Controlled Attenuation Parameter
Change in liver stiffness measurement and controlled attenuation parameter measured by transient elastography at 3-month of treatment
Measured: From baseline to 3 months post-procedure
Change in Enhanced Liver Fibrosis Test
The markers of fibrosis assessed in this test comprised hyaluronic acid, tissue inhibitor of metalloproteinase 1 and procollagen III N-terminal peptide; these are elevated during fibrogenesis as a result of activation of the hepatic stellate cell.
Measured: From baseline to 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start2 Feb 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital
- Responsible party
- Principal investigator, Xiangqing Kong, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- shijing5499@jsph.org.cn Kong, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225713
- Sponsor's protocol ID
- PARADISE-NAFLD
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu C, Ma Z, Wang Y, Liu X, Tao L, Zheng D, Guo X, Yang X. Visceral adiposity index as a predictor of NAFLD: A prospective study with 4-year follow-up. Liver Int. 2018 Dec;38(12):2294-2300. doi: 10.1111/liv.13941. Epub 2018 Sep 6.
PubMed 30099825Petta S, Amato MC, Di Marco V, Camma C, Pizzolanti G, Barcellona MR, Cabibi D, Galluzzo A, Sinagra D, Giordano C, Craxi A. Visceral adiposity index is associated with significant fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2012 Jan;35(2):238-47. doi: 10.1111/j.1365-2036.2011.04929.x. Epub 2011 Nov 24.
PubMed 22117531van der Poorten D, Milner KL, Hui J, Hodge A, Trenell MI, Kench JG, London R, Peduto T, Chisholm DJ, George J. Visceral fat: a key mediator of steatohepatitis in metabolic liver disease. Hepatology. 2008 Aug;48(2):449-57. doi: 10.1002/hep.22350.
PubMed 18627003
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease: a Randomized Controlled Trial (PARADISE-NAFLD)
- ClinicalTrials.gov ID
- NCT06225713
- Acronym / sponsor ID
- PARADISE-NAFLD
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic Fatty Liver Disease, Focused ultrasound, Novel method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease.
Detailed description
Visceral adiposity is closely related to the incidence of non-alcoholic fatty liver disease (NAFLD), and it is also directly associated with liver inflammation and fibrosis. Visceral adiposity, via its unique location and enhanced lipolytic activity, releases toxic free fatty acids, which are delivered in high concentrations directly to the liver and lead to the accumulation and storage of hepatic fat. Furthermore, it has been recognized as an important endocrine organ, and a variety of factors secreted by visceral adiposity may lead to an increased risk of NAFLD.
Peri-renal fat is a special type of visceral adiposity which is different from other type of visceral fat in histology, physiology, and functions. The position of peri-renal fat is more stable than other visceral fat. The investigators found that prophylactic perirenal adipose tissue ablation can prevent the development of NAFLD in mice induced by high fat diets, and also this novel focused power ultrasound can rapidly and efficiently promote the peri-renal adipose tissue fibrosis in the model of swine. Moreover, the investigators performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior peri-renal adipose tissue in NAFLD participants, showing that this kind of method was feasible and safe.
In this study, the investigators aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: focused power ultrasound mediated inferior perirenal adipose tissue modificationIn intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting and initiating) |
| sham-control group | Sham comparator | Device: sham-control groupIn sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older at the time of screening.
- Total liver fat content ≥10% measured by MRI-PDFF.
- Body mass index (BMI) ≥ 25 kg/m^2.
- The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm.
- Participants should be willing to sign the informed consent form of the study.
Key exclusion criteria (18 listed)
- History of significant alcohol consumption (significant alcohol consumption was defined as more than 140 g/week in females and more than 210 g/week in males in the last 12months before screening, on average).
- Secondary factors causing hepatic steatosis, including viral hepatitis C, autoimmune hepatitis, total parenteral nutrition, celiac disease, Wilson's disease, hypothyroidism, hereditary hemochromatosis, drug factors (amiodarone, glucocorticoids, methotrexate, tamoxifen), etc.
- Complicating other chronic liver diseases, mainly including viral hepatitis, cholestatic liver disease, drug-induced liver injury, etc.
- Weight change >10% in the past 3 months.
- Clinical or pathological diagnosis of cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focused power ultrasound mediated inferior perirenal adipose tissue modificationThis novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually. | Device | intervention group |
| sham-control groupParticipants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment. | Device | sham-control group |
Primary outcome
Absolute Change in Liver Fat Content
Time frame: From baseline to 3 months post-procedure
Absolute change in liver fat content assessed by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) at 3-month compared with baseline
6 secondary outcomes
Relative Change in Liver Fat Content
Time frame: From baseline to 3 months post-procedure
Proportion of MRI-PDFF Responders
Time frame: From baseline to 3 months post-procedure
Change in Alanine Aminotransferase (ALT)
Time frame: From baseline to 3 months post-procedure
Change in Concentration of Cytokeratin-18
Time frame: From baseline to 3 months post-procedure
Change in Liver Stiffness Measurement and Controlled Attenuation Parameter
Time frame: From baseline to 3 months post-procedure
Change in Enhanced Liver Fibrosis Test
Time frame: From baseline to 3 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 30099825Xu C, Ma Z, Wang Y, Liu X, Tao L, Zheng D, Guo X, Yang X. Visceral adiposity index as a predictor of NAFLD: A prospective study with 4-year follow-up. Liver Int. 2018 Dec;38(12):2294-2300. doi: 10.1111/liv.13941. Epub 2018 Sep 6.
- Background: PubMed 22117531Petta S, Amato MC, Di Marco V, Camma C, Pizzolanti G, Barcellona MR, Cabibi D, Galluzzo A, Sinagra D, Giordano C, Craxi A. Visceral adiposity index is associated with significant fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2012 Jan;35(2):238-47. doi: 10.1111/j.1365-2036.2011.04929.x. Epub 2011 Nov 24.
- Background: PubMed 18627003van der Poorten D, Milner KL, Hui J, Hodge A, Trenell MI, Kench JG, London R, Peduto T, Chisholm DJ, George J. Visceral fat: a key mediator of steatohepatitis in metabolic liver disease. Hepatology. 2008 Aug;48(2):449-57. doi: 10.1002/hep.22350.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shijing5499@jsph.org.cn Kong principal investigator
The First Affiliated Hospital with Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused power ultrasound mediated inferior perirenal adipose tissue modification in people with Non-alcoholic Fatty Liver Disease, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangqing Kong (+8613951610265, kongxq@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Liver Fat Content (time frame: From baseline to 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.