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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06064240
Other study ID # liyu
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date October 1, 2025

Study information

Verified date September 2023
Source The Affiliated Hospital of Qingdao University
Contact yu li, Dr
Phone 18661809631
Email liyu11920@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 1, 2025
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria: - 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. Exclusion criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
We do not have any intervention type
We do not have any intervention type

Locations

Country Name City State
China Qingdao University Affiliated Hospital Qingdao Shandong

Sponsors (1)

Lead Sponsor Collaborator
yu li,MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Body Mass Index The pre-specified outcome was a indicator for evaluating effectiveness of bariatric surgery. before surgery?one ?three?six month after surgery
Primary Liver fat fraction The primary outcome was a indicator for evaluating liver fat content. before surgery?one ?three?six month after surgery
Primary white blood cell The primary outcome was a indicator for evaluating inflammation. before surgery?one ?three?six month after surgery
Primary aspartate aminotransferase The primary outcome was a indicator for evaluating liver function. before surgery?one ?three?six month after surgery
Primary alanine aminotransferase The primary outcome was a indicator for evaluating liver function. before surgery?one ?three?six month after surgery
Primary C-reactive protein The primary outcome was a indicators for evaluating inflammation. before surgery?one ?three?six month after surgery
Primary neutrophile granulocyte The primary outcome was a indicator for evaluating inflammation. before surgery?one ?three?six month after surgery
Secondary low-density lipoprotein The secondary outcome was a indicator for evaluating blood fat. before surgery?one ?three?six month after surgery
Secondary high-density lipoprotein The secondary outcome was a indicator for evaluating blood lipid. before surgery?one ?three?six month after surgery
Secondary glucose The secondary outcome was a indicator for evaluating blood glucose. before surgery?one ?three?six month after surgery
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