Surgical-imaging Research on Obesity (SIRO)

NCT ID: NCT06268262

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obesity

Non-intervention

No interventions assigned to this group

Healthy control

Non-intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.


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

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.


The same criteria as points 3) to 13) above.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Liu, Prof.

Role: CONTACT

+86-15920157720

Facility Contacts

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Kai Liu, M.D/Ph.D

Role: primary

+86-15920157720

References

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Tutor AW, Lavie CJ, Kachur S, Milani RV, Ventura HO. Updates on obesity and the obesity paradox in cardiovascular diseases. Prog Cardiovasc Dis. 2023 May-Jun;78:2-10. doi: 10.1016/j.pcad.2022.11.013. Epub 2022 Dec 5.

Reference Type BACKGROUND
PMID: 36481212 (View on PubMed)

Malone JI, Hansen BC. Does obesity cause type 2 diabetes mellitus (T2DM)? Or is it the opposite? Pediatr Diabetes. 2019 Feb;20(1):5-9. doi: 10.1111/pedi.12787. Epub 2018 Nov 5.

Reference Type BACKGROUND
PMID: 30311716 (View on PubMed)

Schwartz MW, Woods SC, Porte D Jr, Seeley RJ, Baskin DG. Central nervous system control of food intake. Nature. 2000 Apr 6;404(6778):661-71. doi: 10.1038/35007534.

Reference Type BACKGROUND
PMID: 10766253 (View on PubMed)

Raji CA, Meysami S, Hashemi S, Garg S, Akbari N, Gouda A, Chodakiewitz YG, Nguyen TD, Niotis K, Merrill DA, Attariwala R. Visceral and Subcutaneous Abdominal Fat Predict Brain Volume Loss at Midlife in 10,001 Individuals. Aging Dis. 2024 Aug 1;15(4):1831-1842. doi: 10.14336/AD.2023.0820.

Reference Type BACKGROUND
PMID: 37728587 (View on PubMed)

Gutierrez-Cuevas J, Santos A, Armendariz-Borunda J. Pathophysiological Molecular Mechanisms of Obesity: A Link between MAFLD and NASH with Cardiovascular Diseases. Int J Mol Sci. 2021 Oct 27;22(21):11629. doi: 10.3390/ijms222111629.

Reference Type BACKGROUND
PMID: 34769060 (View on PubMed)

Other Identifiers

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XYFY2023-KL045-01

Identifier Type: -

Identifier Source: org_study_id

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