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Study on Brain Function of Obesity Classification

Research on Brain Function of Metabolism-based Artificial Intelligence Assisted Clinical Classification of Obesity

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05892224
Enrollment
150
Registered
2023-06-07
Start date
2022-01-01
Completion date
2025-12-31
Last updated
2023-06-07

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

Conditions

Functional Neuroimaging, Obesity

Keywords

obesity, Functional Neuroimaging, Brain, artificial intelligence

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.

Interventions

PROCEDURELaparoscopic sleeve gastrectomy

Obese patients of different subtypes were all expected to undergo bariatric surgery

Sponsors

Shanghai 10th People's Hospital
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Functional magnetic resonance imaging of brain6 monthsThe subjects underwent fMRI scans before and after eating. Blood oxygen levels depend on functional brain imaging (Blod-fMRI) to collect the brain's local BLOD response (hemodynamic response) caused by the electrical activity of neurons. The stronger the BLOD response, the more excitability of the local brain. A region-of-interest (ROI) approach was applied with the use of masks that were established in an independent study of normal-weight subjects to be markers of satiety or predictors of food choices. ROIs included the left and right ventral striatum (nucleus accumbens), the left and right amygdala, the left and right dorsal striatum (caudate and putamen), the left and right insula, and the medial orbital frontal cortex (mOFC). functional connectivity analysis analyzes the compatibity of temporal signals of two or more pairs of brain regions or the differences in the strength of functional connections under different experimental conditions

Secondary

MeasureTime frameDescription
Waist/hip Ratio12 monthsWHR(waist-hip ratio)=Waist Circumference in centimeter/Hip Circumference in centimeter
DXA(dual energy x-ray absorptiometry)12 monthsDual X-ray Absorptiometry body composition analysis
Abdominal Fat Measurement12 monthsAbdominal Fat Measurement by B-mode Ultrasound
FBG12 monthsfasting blood-glucose in mmol/L
PBG12 monthspostprandial blood-glucose in mmol/L
FINS12 monthsfasting serum insulin in mU/L
PINS12 monthspostprandial insulin in mU/L
ALT12 monthsalanine aminotransferase in U/L
AST12 monthsaspartate aminotransferase in U/L
UA12 monthsUric acid in umol/L
HOMA-IR12 monthsHomeostatic model assessment insulin resistance index=FBG\*FINS/22.5
HbA1c (%)12 monthsGlycated hemoglobin
LDL-C12 monthslow-density lipoprotein cholesterol in mmol/L
HDL-C12 monthsHight-density lipoprotein cholesterol in mmol/L
TT12 monthstotal testosterone in nmol/L
SHBG12 monthssex hormone-binding globulin in nmol/L
BMI12 monthsBMI=weight(kg)/height(m)\^2
FT312 monthsfree triiodothyronine in pmol/L
FT412 monthsfree thyroxine in pmol/L
FT12 monthsfree testosterone (nmol/L)
DHEAS12 monthsDehydroepiandrosterone Sulfate (ug/dl)
PTH12 monthsparathyroid hormone in (ng / L)
25OHD12 months25 hydroxyvitamin D in (nmol / L)
Ca12 monthsserum calcium in (mmol/L)
GLP-112 monthsGlucagon-like peptide-1(pmol/L)
LCN212 monthsLipocalin 2 level
Ghrelin12 monthsGhrelin level
Leptin12 monthsLeptin level
S10012 monthsS100 protein level
GFAP12 monthsGlial fibrillary acidic protein level
TEFQ-R2112 monthsThe TFEQ-R21 consisted of 21 items rated on a four-point Likert scale. We averaged the scores (ranging from 1 to 4) for the overall items as well as the items within the subdomain of each item, i.e., EE, UE, and CR, where a higher score indicated a more dysfunctional eating behavior.
HADS12 monthsHADS consists of two subscales: HADS-A, designed to detect anxious states, and HADS-D, designed to detect depressive states. Each subscale consists of seven items with a 4-point ordinal response format. Scores ranges from 0 to 21 in each subscale, with higher scores indicating higher levels of anxious or depressive state. Participants answer each item thinking of how they felt and/or behaved during the past week.
TSH12 monthsthyroid stimulating hormone in μIU/ml

Countries

China

Contacts

Primary ContactShen Qu, Dr.
qushencn@hotmail.com(86)021-66301004

Outcome results

None listed

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