Clinical trial NCT05892224: Study on Brain Function of Obesity Classification
Official title: Research on Brain Function of Metabolism-based Artificial Intelligence Assisted Clinical Classification of Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Functional Neuroimaging
Keywords: obesity
Functional Neuroimaging
Brain
artificial intelligence
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

Brief summary: The purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. 120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

Detailed description: Although the investigators have clinically observed significant differences in appetite and metabolic status in patients with the above four types of obesity, the brain functional characteristics of different obesity subtypes and their relationship with metabolic markers are still unclear. Based on this, in this project, the investigators plan to explore further the similarities and differences in brain function in patients with four subtypes of obesity and the relationship between brain function changes after weight loss and metabolic improvement and the occurrence of complications.

120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, and 12 months after laparoscopic sleeve gastrectomy (LSG). Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative. Resting and task state functional magnetic resonance imaging (fMRI) measurements were performed at baseline for all participants at two-time points before and after meals. Measurements were repeated in obese patients 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* age ranged from 16-65 years old
* BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut-off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Exclusion Criteria:

* secondary causes of obesity such as hypothalamic obesity, Cushing syndrome, hypophysis dysfunction, etc
* pregnancy or location
* contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc
* severe heart, liver, and kidney dysfunction
* organic and systemic diseases intolerant of surgery.

Primary outcomes:
measure: Functional magnetic resonance imaging of brain
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 12 months
measure: Waist/hip Ratio
timeFrame: 12 months
measure: DXA(dual energy x-ray absorptiometry)
timeFrame: 12 months
measure: Abdominal Fat Measurement
timeFrame: 12 months
measure: FBG
timeFrame: 12 months
measure: PBG
timeFrame: 12 months
measure: FINS
timeFrame: 12 months
measure: PINS
timeFrame: 12 months
measure: ALT
timeFrame: 12 months
measure: AST
timeFrame: 12 months
measure: UA
timeFrame: 12 months
measure: HOMA-IR
timeFrame: 12 months
measure: HbA1c (%)
timeFrame: 12 months
measure: LDL-C
timeFrame: 12 months
measure: HDL-C
timeFrame: 12 months
measure: TT
timeFrame: 12 months
measure: SHBG
timeFrame: 12 months
measure: TSH
timeFrame: 12 months
measure: FT3
timeFrame: 12 months
measure: FT4
timeFrame: 12 months
measure: FT
timeFrame: 12 months
measure: DHEAS
timeFrame: 12 months
measure: PTH
timeFrame: 12 months
measure: 25OHD
timeFrame: 12 months
measure: Ca
timeFrame: 12 months
measure: GLP-1
timeFrame: 12 months
measure: LCN2
timeFrame: 12 months
measure: Ghrelin
timeFrame: 12 months
measure: Leptin
timeFrame: 12 months
measure: S100
timeFrame: 12 months
measure: GFAP
timeFrame: 12 months
measure: TEFQ-R21
timeFrame: 12 months
measure: HADS
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Dr.
role: STUDY_CHAIR
References: