Adiposity, Bariatric Surgery Candidate, Fat Redistribution
Conditions
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.
Interventions
None listed
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | Baseline and 3 months after sugery | Body mass index of participants (unite in kg/m2) |
| Waist circumference | Baseline and 3 months after sugery | Waist circumference of participants (unite in cm) |
| Hip circumference | Baseline and 3 months after sugery | Hip circumference of participants (unite in cm) |
| Fasting plasma glucose | Baseline and 3 months after sugery | Fasting plasma glucose of participants (unite in mmol/L) |
| Glycated hemoglobin |glycosylated hemoglobin | Baseline and 3 months after sugery | Glycated hemoglobin \|glycosylated hemoglobin of participants (unite in %) |
| Fasting insulin | Baseline and 3 months after sugery | Fasting insulin of participants (unite in uU/mL) |
| Fasting C-peptide | Baseline and 3 months after sugery | Fasting C-peptide of participants (unite in ng/mL) |
| Homeostatic Model Assessment of Insulin Resistance | Baseline and 3 months after sugery | Homeostatic Model Assessment of Insulin Resistance of participants |
| Age | Baseline | Age of participants (unite in year) |
| High-Density Lipoprotein Cholesterol | Baseline and 3 months after sugery | High-Density Lipoprotein Cholesterol of participants (unite in mmol/L) |
| Cholesterol | Baseline and 3 months after sugery | Cholesterol of participants (unite in mmol/L) |
| Triglyceride | Baseline and 3 months after sugery | Triglyceride of participants (unite in mmol/L) |
| Subcutaneous Fat Area | Baseline and 3 months after sugery | Subcutaneous Fat Area of participants evaluated with MRI (unite in cm3) |
| Visceral Fat Area | Baseline and 3 months after sugery | Visceral Fat Area of participants evaluated with MRI (unite in cm3) |
| Liver Fat Percentage | Baseline and 3 months after sugery | Liver Fat Percentage of participants evaluated with MRI (unite in %) |
| Pancreatic Fat Percentage | Baseline and 3 months after sugery | Pancreatic Fat Percentage of participants evaluated with MRI (unite in %) |
| Low-Density Lipoprotein Cholesterol | Baseline and 3 months after sugery | Low-Density Lipoprotein Cholesterol of participants (unite in mmol/L) |
| Gender | Baseline | Gender of participants |
| Duration of Type 2 diabetes | Baseline | Duration of Type 2 diabetes of participants (unite in year) |
| Number of medicine use | Baseline and 3 months after sugery | Number of medicine use of participants |
| Weight | Baseline and 3 months after sugery | Weight of participants (unite in kg) |
Countries
China
Outcome results
None listed