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Completed

NCT Number: NCT05387382

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.

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Key information

Conditions

Bariatric Surgery Candidate Adiposity Body Weight Fat Redistribution Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from Baseline Subcutaneous Fat Area at 3 months after bariatric surgery

    Time frame: Baseline and 3 months after sugery

    Change from baseline subcutaneous fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.

  2. Change from Baseline Visceral Fat Area at 3 months after bariatric surgery

    Time frame: Baseline and 3 months after sugery

    Change from baseline visceral fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.

  3. Change from Baseline Liver Fat Percentage at 3 months after bariatric surgery

    Time frame: Baseline and 3 months after sugery

    Change from baseline liver fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.

  4. Change from Baseline Pancreatic Fat Percentage at 3 months after bariatric surgery

    Time frame: Baseline and 3 months after sugery

    Change from baseline pancreatic fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.

Secondary outcomes

  1. Correlation coefficient of trunk fat change with change in metabolism indicators

    Time frame: Baseline and 3 months after sugery

    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.

Other outcomes

  1. Age

    Time frame: Baseline

    Age of participants (unite in year)

  2. Gender

    Time frame: Baseline

    Gender of participants

  3. Duration of Type 2 diabetes

    Time frame: Baseline

    Duration of Type 2 diabetes of participants (unite in year)

  4. Number of medicine use

    Time frame: Baseline and 3 months after sugery

    Number of medicine use of participants

  5. Weight

    Time frame: Baseline and 3 months after sugery

    Weight of participants (unite in kg)

  6. Body mass index

    Time frame: Baseline and 3 months after sugery

    Body mass index of participants (unite in kg/m2)

  7. Waist circumference

    Time frame: Baseline and 3 months after sugery

    Waist circumference of participants (unite in cm)

  8. Hip circumference

    Time frame: Baseline and 3 months after sugery

    Hip circumference of participants (unite in cm)

  9. Fasting plasma glucose

    Time frame: Baseline and 3 months after sugery

    Fasting plasma glucose of participants (unite in mmol/L)

  10. Glycated hemoglobin |glycosylated hemoglobin

    Time frame: Baseline and 3 months after sugery

    Glycated hemoglobin |glycosylated hemoglobin of participants (unite in %)

  11. Fasting insulin

    Time frame: Baseline and 3 months after sugery

    Fasting insulin of participants (unite in uU/mL)

  12. Fasting C-peptide

    Time frame: Baseline and 3 months after sugery

    Fasting C-peptide of participants (unite in ng/mL)

  13. Homeostatic Model Assessment of Insulin Resistance

    Time frame: Baseline and 3 months after sugery

    Homeostatic Model Assessment of Insulin Resistance of participants

  14. Low-Density Lipoprotein Cholesterol

    Time frame: Baseline and 3 months after sugery

    Low-Density Lipoprotein Cholesterol of participants (unite in mmol/L)

  15. High-Density Lipoprotein Cholesterol

    Time frame: Baseline and 3 months after sugery

    High-Density Lipoprotein Cholesterol of participants (unite in mmol/L)

  16. Cholesterol

    Time frame: Baseline and 3 months after sugery

    Cholesterol of participants (unite in mmol/L)

  17. Triglyceride

    Time frame: Baseline and 3 months after sugery

    Triglyceride of participants (unite in mmol/L)

  18. Subcutaneous Fat Area

    Time frame: Baseline and 3 months after sugery

    Subcutaneous Fat Area of participants evaluated with MRI (unite in cm3)

  19. Visceral Fat Area

    Time frame: Baseline and 3 months after sugery

    Visceral Fat Area of participants evaluated with MRI (unite in cm3)

  20. Liver Fat Percentage

    Time frame: Baseline and 3 months after sugery

    Liver Fat Percentage of participants evaluated with MRI (unite in %)

  21. Pancreatic Fat Percentage

    Time frame: Baseline and 3 months after sugery

    Pancreatic Fat Percentage of participants evaluated with MRI (unite in %)

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 24, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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