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

NCT05387382 | Completed

• 1 other identifier: kuaiI 22091
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bariatric Surgery Candidate; Adiposity; Fat Redistribution

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Correlation coefficient of trunk fat change with change in metabolism indicators

  Baseline and 3 months after sugery

Other Outcomes (21)

• Age

  Baseline

• Gender

  Baseline

• Duration of Type 2 diabetes

  Baseline

Study Arms (1)

Patients pending bariatric surgery

A continuous cohort of patients pending bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients pending bariatric surgery.

You may qualify if:

• 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.

You may not qualify if:

• Previous history of pancreatitis or pancreatic surgery;
• Serious T2DM complications or organic diseases;
• Alcohol addiction;
• Uncontrolled mental illness.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• Cui B, Duan J, Zhu L, Wang G, Sun X, Su Z, Liao Y, Yi B, Li P, Li W, Song Z, Li Z, Tang H, Rong P, Zhu S. Effect of laparoscopic sleeve gastrectomy on mobilization of site-specific body adipose depots: a prospective cohort study. Int J Surg. 2023 Oct 1;109(10):3013-3020. doi: 10.1097/JS9.0000000000000573.

  PMID: 37352520 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for estimates of metabolism indicators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaihong Zhu, M.D.

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: May 20, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2022-05

Locations

CN (1)