Non-Alcoholic Fatty Liver DiseaseNCT06064240
Liver Fat Content and Bariatric Surgery
An observational study of Non-Alcoholic Fatty Liver Disease and Bariatric Surgery, run by yu li，MD at 1 site in China.
Trial summary
On the basis of previous research, this subject intends to evaluate the liver improvement of patients with liver disease after weight loss by MRI, and quantify it by extracting features, so as to provide a new method to judge the liver status of patients with liver disease, and to evaluate the correlation between the… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Bariatric Surgery, Magnetic Resonance Imaging
- What is being tested?
- We do not have any intervention type
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Oct 2025
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The major Study Population were who had accept the bariatric surgery.
Who may be able to join
- 16 years old < age < 60 years old
- BMI > 32kg/m2
- No previous drinking history; weekly drinking of males < 210g and females < 140g in 12 months
- Preoperative auxiliary examination supports the diagnosis of fatty liver, and liver MRI examination
- Previous attempts to lose weight are ineffective
- Complete case data.
Who cannot join
- Secondary obesity
- History of drinking or excessive drinking (in the past 12 months, male's weekly alcohol intake was ≥210g, female's weekly alcohol intake was ≥ 140g)
- Other diseases causing abnormal liver function
- Body mass index < 28kg/m2
- Poor compliance or self-control, unable to follow the dietary guidance after operation
- Those who cannot complete the follow-up
Trial locations and contacts
1 site in 1 country.
xin li, Dr contact
China1 site, 1 recruiting
- Recruiting
Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
liyu li, Dr, 18661809631, liyu11920@hotmail.com
About this study
Official title: Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI
On the basis of previous research, this subject intends to evaluate the liver improvement of patients with liver disease after weight loss by MRI, and quantify it by extracting features, so as to provide a new method to judge the liver status of patients with liver disease, and to evaluate the correlation between the inflammatory status of patients and the quantitative features of MRI, and try to explain the reasons for the improvement of fatty liver status of patients with liver disease after weight loss. To provide a new theoretical basis for fatty liver and systemic inflammatory liver damage in patients with liver disease after weight loss surgery, and to link them, and try to explain the improvement of fatty liver in patients with liver disease through the reduction of systemic inflammatory level.
Read the detailed description
This study is a prospective study to explore the improvement of fatty liver and severe state of the whole body in patients with liver disease undergoing weight-loss surgery. The research object is obese patients who underwent laparoscopic sleeve gastrectomy in our hospital. According to the standard of accepting the discharge, about 50 patients were selected and divided into groups according to preoperative, postoperative one month, postoperative three months and postoperative six months.All patients underwent routine sequence examinations using a Siemens 3.0T MRI scanner (MAGNETOM Prisma, Siemens Healthcare, Munich, Germany).This study investigates alterations in NAFLD among patients with obesity who underwent bariatric surgery using MRI-PDFF and MRS techniques. Additionally, we evaluated the factors that may influence these changes in patients after the surgical procedure.
- Being tested
- We do not have any intervention type
- 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.
We do not have any intervention typeOther
We do not have any intervention type
| Study group | Role | What they receive |
|---|---|---|
| Before operation, 1 month after operation, 3 months after operation and 6 months after operation. | Patients who underwent bariatric surgery were followed up regularly before and after surgery. Receives: Other: We do not have any intervention type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat fraction
The primary outcome was a indicator for evaluating liver fat content.
Measured: before surgery、one 、three、six month after surgery
white blood cell
The primary outcome was a indicator for evaluating inflammation.
Measured: before surgery、one 、three、six month after surgery
aspartate aminotransferase
The primary outcome was a indicator for evaluating liver function.
Measured: before surgery、one 、three、six month after surgery
alanine aminotransferase
The primary outcome was a indicator for evaluating liver function.
Measured: before surgery、one 、three、six month after surgery
C-reactive protein
The primary outcome was a indicators for evaluating inflammation.
Measured: before surgery、one 、three、six month after surgery
neutrophile granulocyte
The primary outcome was a indicator for evaluating inflammation.
Measured: before surgery、one 、three、six month after surgery
Secondary outcomes (3)
low-density lipoprotein
The secondary outcome was a indicator for evaluating blood fat.
Measured: before surgery、one 、three、six month after surgery
high-density lipoprotein
The secondary outcome was a indicator for evaluating blood lipid.
Measured: before surgery、one 、three、six month after surgery
glucose
The secondary outcome was a indicator for evaluating blood glucose.
Measured: before surgery、one 、three、six month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 May 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Oct 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.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yu li，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yu li，MD, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064240
- Sponsor's protocol ID
- liyu
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI
- ClinicalTrials.gov ID
- NCT06064240
- Acronym / sponsor ID
- liyu
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- yu li，MDUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Oct 2023 (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.
On the basis of previous research, this subject intends to evaluate the liver improvement of patients with liver disease after weight loss by MRI, and quantify it by extracting features, so as to provide a new method to judge the liver status of patients with liver disease, and to evaluate the correlation between the inflammatory status of patients and the quantitative features of MRI, and try to explain the reasons for the improvement of fatty liver status of patients with liver disease after weight loss. To provide a new theoretical basis for fatty liver and systemic inflammatory liver damage in patients with liver disease after weight loss surgery, and to link them, and try to explain the improvement of fatty liver in patients with liver disease through the reduction of systemic inflammatory level.
Detailed description
This study is a prospective study to explore the improvement of fatty liver and severe state of the whole body in patients with liver disease undergoing weight-loss surgery. The research object is obese patients who underwent laparoscopic sleeve gastrectomy in our hospital. According to the standard of accepting the discharge, about 50 patients were selected and divided into groups according to preoperative, postoperative one month, postoperative three months and postoperative six months.All patients underwent routine sequence examinations using a Siemens 3.0T MRI scanner (MAGNETOM Prisma, Siemens Healthcare, Munich, Germany).This study investigates alterations in NAFLD among patients with obesity who underwent bariatric surgery using MRI-PDFF and MRS techniques. Additionally, we evaluated the factors that may influence these changes in patients after the surgical procedure.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before operation, 1 month after operation, 3 months after operation and 6 months after operation. | – | Other: We do not have any intervention typePatients who underwent bariatric surgery were followed up regularly before and after surgery. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The major Study Population were who had accept the bariatric surgery.
Key inclusion criteria (6 listed)
- 16 years old < age < 60 years old
- BMI > 32kg/m2
- No previous drinking history; weekly drinking of males < 210g and females < 140g in 12 months
- Preoperative auxiliary examination supports the diagnosis of fatty liver, and liver MRI examination
- Previous attempts to lose weight are ineffective
Key exclusion criteria (6 listed)
- Secondary obesity
- History of drinking or excessive drinking (in the past 12 months, male's weekly alcohol intake was ≥210g, female's weekly alcohol intake was ≥ 140g)
- Other diseases causing abnormal liver function
- Body mass index < 28kg/m2
- Poor compliance or self-control, unable to follow the dietary guidance after operation
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 |
|---|---|---|
| We do not have any intervention typeWe do not have any intervention type | Other | Before operation, 1 month after operation, 3 months after operation and 6 months after operation. |
Primary outcome
Liver fat fraction
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicator for evaluating liver fat content.
white blood cell
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicator for evaluating inflammation.
aspartate aminotransferase
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicator for evaluating liver function.
alanine aminotransferase
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicator for evaluating liver function.
C-reactive protein
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicators for evaluating inflammation.
neutrophile granulocyte
Time frame: before surgery、one 、three、six month after surgery
The primary outcome was a indicator for evaluating inflammation.
3 secondary outcomes
low-density lipoprotein
Time frame: before surgery、one 、three、six month after surgery
high-density lipoprotein
Time frame: before surgery、one 、three、six month after surgery
glucose
Time frame: before surgery、one 、three、six month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
xin li, Dr contact
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 and Bariatric Surgery, run by yu li，MD 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 6 inclusion and 6 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 3 Oct 2023. 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 yu li, Dr (18661809631, liyu11920@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat fraction (time frame: before surgery、one 、three、six month after surgery). The study lists 6 primary outcomes in all. 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 3 Oct 2023.