Clinical trial NCT06064240: Liver Fat Content and Bariatric Surgery
Official title: Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Bariatric Surgery
Magnetic Resonance Imaging
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The major Study Population were who had accept the bariatric surgery.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver fat fraction
timeFrame: before surgery、one 、three、six month after surgery
measure: white blood cell
timeFrame: before surgery、one 、three、six month after surgery
measure: aspartate aminotransferase
timeFrame: before surgery、one 、three、six month after surgery
measure: alanine aminotransferase
timeFrame: before surgery、one 、three、six month after surgery
measure: C-reactive protein
timeFrame: before surgery、one 、three、six month after surgery
measure: neutrophile granulocyte
timeFrame: before surgery、one 、three、six month after surgery
Secondary outcomes:
measure: low-density lipoprotein
timeFrame: before surgery、one 、three、six month after surgery
measure: high-density lipoprotein
timeFrame: before surgery、one 、three、six month after surgery
measure: glucose
timeFrame: before surgery、one 、three、six month after surgery
Other outcomes:
measure: Body Mass Index
timeFrame: before surgery、one 、three、six month after surgery
Locations:
city: Qingdao
country: China
facility: Qingdao University Affiliated Hospital
state: Shandong
Study officials:
References: