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Surgical-imaging Research on Obesity (SIRO)

Surgical-imaging Combined Research on Obesity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06268262
Enrollment
200
Registered
2024-02-20
Start date
2023-03-01
Completion date
2028-12-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Obesity, Overweight, MRI, Bariatric surgery, Fatty liver

Brief summary

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.

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.

Interventions

None listed

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Imaging parameters of obesitybaseline, 6th monthBrain cortical thickness in millimeter

Secondary

MeasureTime frameDescription
Neurotransmitter, inflammatory factors and hormones related to obesity in blood samplebaseline, 6th monthThe level of 5-HT,GABA, TNF-a and estradiol in ng/L
Neurotransmitter, inflammatory factors and hormones relating to obesity in blood samplebaseline, 6th monthThe level of BDNF in ng/ml
Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissuebaselineScreen and analyzing the DNA and RNA related to obesity

Countries

China

Contacts

Primary ContactKai Liu, Prof.
liu-k@hotmail.com+86-15920157720

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026