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Brain-gut axis remodeling and brain function changes after bariatric surgery: a prospective clinical trial

Brain-gut axis remodeling and brain function changes after bariatric surgery: a prospective clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038720
Enrollment
Unknown
Registered
2020-09-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Obesity

Interventions

S:Bariatric surgery

Sponsors

Shanghai Jiaotong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Surgical group (1) Aged 16-65 years, no gender limit; (2) Agree and voluntarily participate in the experiment; (3) Educated with junior high school and above, with a certain degree of cognitive understanding; (4) Indications in line with the " Surgical Treatment for Obesity and Type 2 Diabetes: Chinese Guidelines (2019 Edition)"; Control group (1) According to nearest-neighbor method to include healthy controls and match the obesity in terms of age, gender, and years of education. (2) BMI (17.9-23.9); (3) Agree and voluntarily participate in the experiment; (4) Educated with junior high school and above; (5) Possess a certain degree of cognitive understanding; (6) Age > 18 years, or obtain the consent of the guardian.

Exclusion criteria

Exclusion criteria: (1) Meet the current standards for severe depression, bipolar disorder, schizophrenia, any mental illness (including drug-induced mental illness) and current drug-induced mood disorders; (2) Suffer from delusion, dementia, amnesia, obsessive-compulsive disorder, post-traumatic stress disorder, anxiety disorder, any personality disorder, cognitive disorder or dissociative disorder; (3) With serious negative ideas and behaviors; (4) (Be careful not to perform MRI) There are metal implants in the skull, cochlear implants, increased intracranial pressure, brain trauma, skull insufficiency, encephalitis, brain tumors; (5) Suffer from cardiovascular and cerebrovascular diseases such as hypertension; (6) With sleep deprivation; (7) There is cerebral calcification and cerebral microhemorrhage. (8) With any neurological diseases, epilepsy, Parkinson's, stroke, etc., have a family history of epilepsy, use anticonvulsants; (9) Pregnancy. (10) Those who have previously undergone bariatric surgery or major gastrointestinal surgery; (11) With history of excessive drinking: the alcohol equivalent of men's drinking in the past 12 months is greater than 30g/d, and the female is greater than 20g/d; (12) There is a history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.; (13) Diagnosed or suspected of malignant tumor; (14) Those with hepatitis B virus infection, that is, those with hepatitis B surface antigen HBsAg (+); (15) People infected with HIV; (16) There are other serious diseases that affect the evaluation of this research and cannot cooperate; (17) Those who cannot understand the procedures and methods of this clinical study, refuse to participate and refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
EEG detection;

Secondary

MeasureTime frame
Questionnaire;Behavior test;MRI;Serum biochemical test;

Countries

China

Contacts

Public ContactHongwei Zhang

Department of Metabolic & Bariatric Surgery, Shanghai Jiaotong University Affiliated Sixth People's Hospital

zhw00sub@163.com+86 13917135942

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026