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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05387382
• Other study ID #: kuaiI 22091
• Status: Completed
• Start date: May 20, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: May 2022
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Bariatric Surgery Candidate
• Obesity

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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