Surgical-imaging Research on Obesity (SIRO)

NCT06268262 | Recruiting

• 1 other identifier: XYFY2023-KL045-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Obesity; Overweight; MRI; Bariatric surgery; Fatty liver

Outcome Measures

Primary Outcomes (3)

• Imaging parameters of obesity

  Brain cortical thickness in millimeter

  baseline, 6th month

• Imaging parameters of obesity

  The volume of left ventricle in cubic millimeter

  baseline, 6th month

• Imaging parameters of obesity

  Fat fraction of liver (dividing the in-phase fat attenuation signal by the out-phase fat attenuation signal)

  baseline, 6th month

Secondary Outcomes (4)

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

  baseline, 6th month

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

  baseline, 6th month

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

  baseline, 6th month

• Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue

  baseline

Study Arms (2)

Obesity

Non-intervention

Healthy control

Non-intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 36481212 BACKGROUND

• 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.

  PMID: 30311716 BACKGROUND

• 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.

  PMID: 10766253 BACKGROUND

• 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.

  PMID: 37728587 BACKGROUND

• 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.

  PMID: 34769060 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples, biopsied liver tissue, biopsied fat tissue, gastric tissue

MeSH Terms

Conditions

Overweight; Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Central Study Contacts

Kai Liu, Prof.

CONTACT

+86-15920157720; liu-k@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)