Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms

Completed

• Conditions: Bariatric Surgery Candidate; Adiposity; Fat Redistribution

• Registration Number: NCT05387382
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study Start: 2022-05-20
• Study First Posted: 2022-05-24
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Visceral Fat Area at 3 months after bariatric surgery	Baseline and 3 months after sugery	Change from baseline visceral fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Liver Fat Percentage at 3 months after bariatric surgery	Baseline and 3 months after sugery	Change from baseline liver fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Subcutaneous Fat Area at 3 months after bariatric surgery	Baseline and 3 months after sugery	Change from baseline subcutaneous fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Pancreatic Fat Percentage at 3 months after bariatric surgery	Baseline and 3 months after sugery	Change from baseline pancreatic fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient of trunk fat change with change in metabolism indicators	Baseline and 3 months after sugery	Correlation coefficient of trunk fat changes with changes in metabolism indicators.; 1. Trunk fat changes included changes from baseline subcutaneous fat area (unite in cm3), visceral fat area (unite in cm3), liver fat percentage (unite in %), pancreatic fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.; 2. Changes in metabolism indicators included changes from baseline Fasting plasma glucose (unite in mmol/L), Glycated hemoglobin (unite in %), Fasting insulin (unite in uU/mL), Fasting C-peptide (unite in ng/mL), Homeostatic Model Assessment of Insulin Resistance, Low-Density Lipoprotein Cholesterol (unite in mmol/L), High-Density Lipoprotein Cholesterol (unite in mmol/L), Cholesterol (unite in mmol/L), Triglyceride (unite in mmol/L).; 3. We used Pearson Correlation Analysis to calculate the correlation coefficient of trunk fat changes with changes in metabolism indicators.

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China