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

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

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Adiposity; Fat Redistribution

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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients pending bariatric surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients pending bariatric surgery; A continuous cohort of patients pending bariatric surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficient of trunk fat change with change in metabolism indicators	Correlation coefficient of trunk fat changes with changes in metabolism indicators.; 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.; 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).; We used Pearson Correlation Analysis to calculate the correlation coefficient of trunk fat changes with changes in metabolism indicators.	Baseline and 3 months after sugery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Gender of participants	Baseline
Age	Age of participants (unite in year)	Baseline
Duration of Type 2 diabetes	Duration of Type 2 diabetes of participants (unite in year)	Baseline
Number of medicine use	Number of medicine use of participants	Baseline and 3 months after sugery
Weight	Weight of participants (unite in kg)	Baseline and 3 months after sugery
Body mass index	Body mass index of participants (unite in kg/m2)	Baseline and 3 months after sugery
Waist circumference	Waist circumference of participants (unite in cm)	Baseline and 3 months after sugery
Hip circumference	Hip circumference of participants (unite in cm)	Baseline and 3 months after sugery
Fasting plasma glucose	Fasting plasma glucose of participants (unite in mmol/L)	Baseline and 3 months after sugery
Glycated hemoglobin |glycosylated hemoglobin	Glycated hemoglobin |glycosylated hemoglobin of participants (unite in %)	Baseline and 3 months after sugery
Fasting insulin	Fasting insulin of participants (unite in uU/mL)	Baseline and 3 months after sugery
Fasting C-peptide	Fasting C-peptide of participants (unite in ng/mL)	Baseline and 3 months after sugery
Homeostatic Model Assessment of Insulin Resistance	Homeostatic Model Assessment of Insulin Resistance of participants	Baseline and 3 months after sugery
Low-Density Lipoprotein Cholesterol	Low-Density Lipoprotein Cholesterol of participants (unite in mmol/L)	Baseline and 3 months after sugery
High-Density Lipoprotein Cholesterol	High-Density Lipoprotein Cholesterol of participants (unite in mmol/L)	Baseline and 3 months after sugery
Cholesterol	Cholesterol of participants (unite in mmol/L)	Baseline and 3 months after sugery
Triglyceride	Triglyceride of participants (unite in mmol/L)	Baseline and 3 months after sugery
Subcutaneous Fat Area	Subcutaneous Fat Area of participants evaluated with MRI (unite in cm3)	Baseline and 3 months after sugery
Visceral Fat Area	Visceral Fat Area of participants evaluated with MRI (unite in cm3)	Baseline and 3 months after sugery
Liver Fat Percentage	Liver Fat Percentage of participants evaluated with MRI (unite in %)	Baseline and 3 months after sugery
Pancreatic Fat Percentage	Pancreatic Fat Percentage of participants evaluated with MRI (unite in %)	Baseline and 3 months after sugery

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Shaihong Zhu, M.D., The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: kuaiI 22091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No