Liver Fat Content and Bariatric Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Non-Alcoholic Fatty Liver Disease; Bariatric Surgery
• Intervention / Treatment: Other: We do not have any intervention type

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: yu li, Dr; Phone Number: 18661809631; Email: liyu11920@hotmail.com
• Study Contact Backup: Name: xin li, Dr; Phone Number: 15065327781

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Qingdao University Affiliated Hospital
      • Contact: liyu li, Dr; Phone Number: 18661809631; Email: liyu11920@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The major Study Population were who had accept the bariatric surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: We do not have any intervention type; We do not have any intervention type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fat fraction	The primary outcome was a indicator for evaluating liver fat content.	before surgery、one 、three、six month after surgery
white blood cell	The primary outcome was a indicator for evaluating inflammation.	before surgery、one 、three、six month after surgery
aspartate aminotransferase	The primary outcome was a indicator for evaluating liver function.	before surgery、one 、three、six month after surgery
alanine aminotransferase	The primary outcome was a indicator for evaluating liver function.	before surgery、one 、three、six month after surgery
C-reactive protein	The primary outcome was a indicators for evaluating inflammation.	before surgery、one 、three、six month after surgery
neutrophile granulocyte	The primary outcome was a indicator for evaluating inflammation.	before surgery、one 、three、six month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
low-density lipoprotein	The secondary outcome was a indicator for evaluating blood fat.	before surgery、one 、three、six month after surgery
high-density lipoprotein	The secondary outcome was a indicator for evaluating blood lipid.	before surgery、one 、three、six month after surgery
glucose	The secondary outcome was a indicator for evaluating blood glucose.	before surgery、one 、three、six month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	The pre-specified outcome was a indicator for evaluating effectiveness of bariatric surgery.	before surgery、one 、three、six month after surgery

Collaborators and Investigators

• Sponsor: yu li，MD

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: liyu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No