Surgical-imaging Research on Obesity (SIRO)

March 13, 2024 updated by: The Affiliated Hospital of Xuzhou Medical University

Surgical-imaging Combined Research on Obesity

The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In 2016, the prevalence of obesity has already reached 13% of obesity and about 40% overweight worldwide. There is no doubt that obesity is linked to a broad spectrum of diseases，such as cardiovascular diseases, fatty liver diseases, polycystic ovarian syndrome and even central nervous systems disorders. For instance, in a review, author indicated the insulin resistance of T2DM occurs primarily in the muscles of lean individuals before they become obese. The central nervous system, especially the hypothalamus, has always considered to be the regulation center of food intake and hormonal regulation of energy homeostasis. In turn, obesity may worsen the regularity function of nervous system in several pathway. Based on the previous findings, the investigators hypothesized that a serious alterations of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. The investigators plan to integrate the MR imaging, biological and epidemiological data thoroughly to investigate the alterations of the body that induced by obese and also followup the alterations that after surgery.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aged between 18 and 65, regardless of gender. Initially diagnosed as obesity (BMI>28) and plan to undergo bariatric surgery.

Description

Inclusion Criteria for obesity group:

Meeting the obesity criteria (BMI > 28); 2) Meeting the indications for bariatric surgery, planning to undergo surgery for the first time; 3) Age between 18-65 years old, no gender restrictions; 4) Right-handed, of Han ethnicity; 5) Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.

Inclusion Criteria for the Control Group:

  1. Healthy volunteers with a BMI between 18.5-23.9;
  2. Age between 18-65 years old, no gender restrictions;
  3. Right-handed, of Han ethnicity;
  4. Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.

Exclusion Criteria for obesity group:

  1. Secondary obesity caused by other organic diseases or medication (such as hormone use, etc.);
  2. Unable to undergo surgery as planned;
  3. Pregnant or breastfeeding;
  4. Low cognitive ability and incapable of cooperating with the study;
  5. Eating disorders;
  6. Alcohol or drug dependence;
  7. Meeting the criteria for organic mental disorders, severe mental disorders (schizophrenia, etc.), or other serious mental illnesses requiring clinical intervention;
  8. Contraindications for MR scanning (pacemakers, cochlear implants, metal objects in the body, claustrophobia, weight exceeding the machine's load limit, etc.);
  9. History of neurological organic diseases (brain tumors, epilepsy, cerebrovascular accidents, severe head trauma, etc.);
  10. History of congenital heart disease (myocardial infarction, severe arrhythmias, heart failure, cardiomyopathy, rheumatic heart disease, congenital heart disease, etc.);
  11. Severe liver, kidney, lung, digestive dysfunction, endocrine, and blood system diseases;
  12. Active infections within the last two weeks (fever, upper respiratory infection, acute gastroenteritis, etc.);
  13. Use of drugs affecting the nervous system or psychotropic drugs within the last six months.

Exclusion Criteria for the Control Group:

The same criteria as points 3) to 13) above.

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

Cohorts and Interventions

Group / Cohort
Obesity
Non-intervention
Healthy control
Non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging parameters of obesity
Time Frame: baseline, 6th month
The volume of left ventricle in cubic millimeter
baseline, 6th month
Imaging parameters of obesity
Time Frame: baseline, 6th month
Brain cortical thickness in millimeter
baseline, 6th month
Imaging parameters of obesity
Time Frame: baseline, 6th month
Fat fraction of liver (dividing the in-phase fat attenuation signal by the out-phase fat attenuation signal)
baseline, 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
Time Frame: baseline, 6th month
The level of 5-HT，GABA, TNF-a and estradiol in ng/L
baseline, 6th month
Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample
Time Frame: baseline, 6th month
The level of BDNF in ng/ml
baseline, 6th month
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
Time Frame: baseline, 6th month
cortisol in μg/L
baseline, 6th month
Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue
Time Frame: baseline
Screen and analyzing the DNA and RNA related to obesity
baseline

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2023-KL045-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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