Liver Fat Content and Bariatric Surgery

Sponsor
yu li,MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT06064240
Collaborator
(none)
50
1
41
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Liver fat fraction [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicator for evaluating liver fat content.

  2. white blood cell [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicator for evaluating inflammation.

  3. aspartate aminotransferase [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicator for evaluating liver function.

  4. alanine aminotransferase [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicator for evaluating liver function.

  5. C-reactive protein [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicators for evaluating inflammation.

  6. neutrophile granulocyte [before surgery、one 、three、six month after surgery]

    The primary outcome was a indicator for evaluating inflammation.

Secondary Outcome Measures

  1. low-density lipoprotein [before surgery、one 、three、six month after surgery]

    The secondary outcome was a indicator for evaluating blood fat.

  2. high-density lipoprotein [before surgery、one 、three、six month after surgery]

    The secondary outcome was a indicator for evaluating blood lipid.

  3. glucose [before surgery、one 、three、six month after surgery]

    The secondary outcome was a indicator for evaluating blood glucose.

Other Outcome Measures

  1. Body Mass Index [before surgery、one 、three、six month after surgery]

    The pre-specified outcome was a indicator for evaluating effectiveness of bariatric surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qingdao University Affiliated Hospital Qingdao Shandong China 266000

Sponsors and Collaborators

  • yu li,MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
yu li,MD, Doctoral, The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT06064240
Other Study ID Numbers:
  • liyu
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023