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

September 17, 2023 updated by: The Third Xiangya Hospital of Central South University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients pending bariatric surgery
A continuous cohort of patients pending bariatric surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months after sugery
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.
Baseline and 3 months after sugery
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.
Baseline and 3 months after sugery
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.
Baseline and 3 months after sugery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

  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.
Baseline and 3 months after sugery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
Gender of participants
Baseline
Age
Time Frame: Baseline
Age of participants (unite in year)
Baseline
Duration of Type 2 diabetes
Time Frame: Baseline
Duration of Type 2 diabetes of participants (unite in year)
Baseline
Number of medicine use
Time Frame: Baseline and 3 months after sugery
Number of medicine use of participants
Baseline and 3 months after sugery
Weight
Time Frame: Baseline and 3 months after sugery
Weight of participants (unite in kg)
Baseline and 3 months after sugery
Body mass index
Time Frame: Baseline and 3 months after sugery
Body mass index of participants (unite in kg/m2)
Baseline and 3 months after sugery
Waist circumference
Time Frame: Baseline and 3 months after sugery
Waist circumference of participants (unite in cm)
Baseline and 3 months after sugery
Hip circumference
Time Frame: Baseline and 3 months after sugery
Hip circumference of participants (unite in cm)
Baseline and 3 months after sugery
Fasting plasma glucose
Time Frame: Baseline and 3 months after sugery
Fasting plasma glucose of participants (unite in mmol/L)
Baseline and 3 months after sugery
Glycated hemoglobin |glycosylated hemoglobin
Time Frame: Baseline and 3 months after sugery
Glycated hemoglobin |glycosylated hemoglobin of participants (unite in %)
Baseline and 3 months after sugery
Fasting insulin
Time Frame: Baseline and 3 months after sugery
Fasting insulin of participants (unite in uU/mL)
Baseline and 3 months after sugery
Fasting C-peptide
Time Frame: Baseline and 3 months after sugery
Fasting C-peptide of participants (unite in ng/mL)
Baseline and 3 months after sugery
Homeostatic Model Assessment of Insulin Resistance
Time Frame: Baseline and 3 months after sugery
Homeostatic Model Assessment of Insulin Resistance of participants
Baseline and 3 months after sugery
Low-Density Lipoprotein Cholesterol
Time Frame: Baseline and 3 months after sugery
Low-Density Lipoprotein Cholesterol of participants (unite in mmol/L)
Baseline and 3 months after sugery
High-Density Lipoprotein Cholesterol
Time Frame: Baseline and 3 months after sugery
High-Density Lipoprotein Cholesterol of participants (unite in mmol/L)
Baseline and 3 months after sugery
Cholesterol
Time Frame: Baseline and 3 months after sugery
Cholesterol of participants (unite in mmol/L)
Baseline and 3 months after sugery
Triglyceride
Time Frame: Baseline and 3 months after sugery
Triglyceride of participants (unite in mmol/L)
Baseline and 3 months after sugery
Subcutaneous Fat Area
Time Frame: Baseline and 3 months after sugery
Subcutaneous Fat Area of participants evaluated with MRI (unite in cm3)
Baseline and 3 months after sugery
Visceral Fat Area
Time Frame: Baseline and 3 months after sugery
Visceral Fat Area of participants evaluated with MRI (unite in cm3)
Baseline and 3 months after sugery
Liver Fat Percentage
Time Frame: Baseline and 3 months after sugery
Liver Fat Percentage of participants evaluated with MRI (unite in %)
Baseline and 3 months after sugery
Pancreatic Fat Percentage
Time Frame: Baseline and 3 months after sugery
Pancreatic Fat Percentage of participants evaluated with MRI (unite in %)
Baseline and 3 months after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Third Xiangya Hospital of Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shaihong Zhu, M.D., The Third XIANGYA Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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