Clinical trial NCT05387382: Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms
Official title: Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Adiposity
Fat Redistribution
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients pending bariatric surgery.

Brief summary: This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms.

Detailed description: This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms. The primary outcome is effects of bariatric surgery on different compositions of trunk fat evaluated with MRI for patients pending bariatric surgery before and 3 months after surgery. The secondary outcome is the associations of trunk fat reduction with improvement in metabolism indicators. Before patients are enrolled in this observational study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the study. Patients who meet the conditions of the study will be required to sign an informed consent form.

Eligibility criteria: Inclusion Criteria:

* BMI of \>27.5 kg/m2 with T2DM;
* BMI of \>32.5 kg/m2 with or without metabolic syndrome;
* Age 18-65 years old;
* T2DM duration \< 15 years.

Exclusion Criteria:

* Previous history of pancreatitis or pancreatic surgery;
* Serious T2DM complications or organic diseases;
* Alcohol addiction;
* Uncontrolled mental illness.

Primary outcomes:
measure: Change from Baseline Subcutaneous Fat Area at 3 months after bariatric surgery
timeFrame: Baseline and 3 months after sugery
measure: Change from Baseline Visceral Fat Area at 3 months after bariatric surgery
timeFrame: Baseline and 3 months after sugery
measure: Change from Baseline Liver Fat Percentage at 3 months after bariatric surgery
timeFrame: Baseline and 3 months after sugery
measure: Change from Baseline Pancreatic Fat Percentage at 3 months after bariatric surgery
timeFrame: Baseline and 3 months after sugery
Secondary outcomes:
measure: Correlation coefficient of trunk fat change with change in metabolism indicators
timeFrame: Baseline and 3 months after sugery
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Duration of Type 2 diabetes
timeFrame: Baseline
measure: Number of medicine use
timeFrame: Baseline and 3 months after sugery
measure: Weight
timeFrame: Baseline and 3 months after sugery
measure: Body mass index
timeFrame: Baseline and 3 months after sugery
measure: Waist circumference
timeFrame: Baseline and 3 months after sugery
measure: Hip circumference
timeFrame: Baseline and 3 months after sugery
measure: Fasting plasma glucose
timeFrame: Baseline and 3 months after sugery
measure: Glycated hemoglobin |glycosylated hemoglobin
timeFrame: Baseline and 3 months after sugery
measure: Fasting insulin
timeFrame: Baseline and 3 months after sugery
measure: Fasting C-peptide
timeFrame: Baseline and 3 months after sugery
measure: Homeostatic Model Assessment of Insulin Resistance
timeFrame: Baseline and 3 months after sugery
measure: Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and 3 months after sugery
measure: High-Density Lipoprotein Cholesterol
timeFrame: Baseline and 3 months after sugery
measure: Cholesterol
timeFrame: Baseline and 3 months after sugery
measure: Triglyceride
timeFrame: Baseline and 3 months after sugery
measure: Subcutaneous Fat Area
timeFrame: Baseline and 3 months after sugery
measure: Visceral Fat Area
timeFrame: Baseline and 3 months after sugery
measure: Liver Fat Percentage
timeFrame: Baseline and 3 months after sugery
measure: Pancreatic Fat Percentage
timeFrame: Baseline and 3 months after sugery
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Shaihong Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: