Non-alcoholic Fatty Liver DiseaseNCT04104282
the Role of plin5 in the Development of Nonalcoholic Fatty Liver Disease.
An observational study of Non-alcoholic Fatty Liver Disease, run by Xijing Hospital at 1 site in China.
Trial summary
To further clarify the role of sequence polymorphism in patatin-like phospholipid domain containing protein 3 in the development of nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 27 Dec 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with was confirmed by clinical presentation, ultrasound and laboratory test. At the same time, participants who enrolled this statistical analysis without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases. (range, 18-75 years).
Who may be able to join
- The diagnosis of simple fatty liver disease was confirmed by clinical presentation, ultrasound, and without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.
Who cannot join
- With long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Department of Ultrasonic Medicine, The Xijing Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710032
Ming Yu, PhD, MD, 15209239680, huihui2807201830@163.com
Huihui Zhou, MD, 18066896622, huihui2807201830@126.com
About this study
Official title: the Role of plin5 in the Development of a Sequence Polymorphism in Patatin-like Phospholipid Domain Containing Protein 3 Polymorphism-associated Nonalcoholic Fatty Liver Disease
To further clarify the role of sequence polymorphism in patatin-like phospholipid domain containing protein 3 in the development of nonalcoholic fatty liver disease.
Read the detailed description
A sequence polymorphism in patatin-like phospholipid domain containing protein 3 is significantly associated with nonalcoholic fatty liver disease, but its mechanism underlying this association remains obscure. We introduce the human samples of liver to clarify the relationship between the expression of plin5 and the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease, analyze the lipid metabolism and lipotoxicity of hepatocytes to elucidate the mechanisms of plin5 in the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease. Our study will contribute to the mechanism of nonalcoholic fatty liver disease, and its prevention and therapy.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic fatty liver disease, Lipid droplets, Plin5
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of non-alcoholic fatty liver disease
Evaluating by ultrasound the severity of non-alcoholic fatty liver disease
Measured: 3 months
Secondary outcomes (1)
The expression of plin5
Evaluating by biochemical methods the expression of plin5 in patients liver tissue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Dec 2016
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Yu, PhD, MD, Study director, The Xijing Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104282
- Sponsor's protocol ID
- KY-20162068-2
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of plin5 in the Development of a Sequence Polymorphism in Patatin-like Phospholipid Domain Containing Protein 3 Polymorphism-associated Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04104282
- Acronym / sponsor ID
- KY-20162068-2
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic fatty liver disease, Lipid droplets, Plin5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 26 Sep 2019 (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.
To further clarify the role of sequence polymorphism in patatin-like phospholipid domain containing protein 3 in the development of nonalcoholic fatty liver disease.
Detailed description
A sequence polymorphism in patatin-like phospholipid domain containing protein 3 is significantly associated with nonalcoholic fatty liver disease, but its mechanism underlying this association remains obscure. We introduce the human samples of liver to clarify the relationship between the expression of plin5 and the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease, analyze the lipid metabolism and lipotoxicity of hepatocytes to elucidate the mechanisms of plin5 in the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease. Our study will contribute to the mechanism of nonalcoholic fatty liver disease, and its prevention and therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with was confirmed by clinical presentation, ultrasound and laboratory test. At the same time, participants who enrolled this statistical analysis without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases. (range, 18-75 years).
Key inclusion criteria (1 listed)
- The diagnosis of simple fatty liver disease was confirmed by clinical presentation, ultrasound, and without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.
Key exclusion criteria (1 listed)
- With long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The severity of non-alcoholic fatty liver disease
Time frame: 3 months
Evaluating by ultrasound the severity of non-alcoholic fatty liver disease
1 secondary outcome
The expression of plin5
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Ming Yu, PhD, MD study director
The Xijing Hospital of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, run by Xijing Hospital at 1 site 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 1 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Ming Yu, PhD, MD (15209239680, huihui2807201830@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of non-alcoholic fatty liver disease (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.