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NCT Number: NCT06268262

Surgical-imaging Research on Obesity (SIRO)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location status: Recruiting

Location contact

Kai Liu, M.D/Ph.D

CONTACT

[email protected]

+86-15920157720

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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:

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

Exclusion criteria

for obesity group:

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

Treatment and study plan

Primary outcomes

  1. Imaging parameters of obesity

    Time frame: baseline, 6th month

    Brain cortical thickness in millimeter

  2. Imaging parameters of obesity

    Time frame: baseline, 6th month

    The volume of left ventricle in cubic millimeter

  3. 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)

Secondary outcomes

  1. 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

  2. Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample

    Time frame: baseline, 6th month

    The level of BDNF in ng/ml

  3. Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample

    Time frame: baseline, 6th month

    cortisol in μg/L

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Liu, Prof.

CONTACT

[email protected]

+86-15920157720

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

Surgical-imaging Combined Research on Obesity

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Feb 20, 2024
Registry last updated
Mar 15, 2024

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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