Liver Fat Content and Bariatric Surgery

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064240
• Other study ID #: liyu
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Fatty Liver
• Liver Diseases
• Magnetic Resonance Imaging
• Non-Alcoholic Fatty Liver Disease

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