Study on Brain Function of Obesity Classification

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892224
• Other study ID #: Brain function in obesity
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Shanghai 10th People's Hospital
• Contact: Shen Qu, Dr.
• Phone: (86)021-66301004
• Email: qushencn[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Functional Neuroimaging
• Obesity

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Obese patients of different subtypes were all expected to undergo bariatric surgery

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging of brain	The 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	6 months
Secondary	BMI	BMI=weight(kg)/height(m)^2	12 months
Secondary	Waist/hip Ratio	WHR(waist-hip ratio)=Waist Circumference in centimeter/Hip Circumference in centimeter	12 months
Secondary	DXA(dual energy x-ray absorptiometry)	Dual X-ray Absorptiometry body composition analysis	12 months
Secondary	Abdominal Fat Measurement	Abdominal Fat Measurement by B-mode Ultrasound	12 months
Secondary	FBG	fasting blood-glucose in mmol/L	12 months
Secondary	PBG	postprandial blood-glucose in mmol/L	12 months
Secondary	FINS	fasting serum insulin in mU/L	12 months
Secondary	PINS	postprandial insulin in mU/L	12 months
Secondary	ALT	alanine aminotransferase in U/L	12 months
Secondary	AST	aspartate aminotransferase in U/L	12 months
Secondary	UA	Uric acid in umol/L	12 months
Secondary	HOMA-IR	Homeostatic model assessment insulin resistance index=FBG*FINS/22.5	12 months
Secondary	HbA1c (%)	Glycated hemoglobin	12 months
Secondary	LDL-C	low-density lipoprotein cholesterol in mmol/L	12 months
Secondary	HDL-C	Hight-density lipoprotein cholesterol in mmol/L	12 months
Secondary	TT	total testosterone in nmol/L	12 months
Secondary	SHBG	sex hormone-binding globulin in nmol/L	12 months
Secondary	TSH	thyroid stimulating hormone in µIU/ml	12 months
Secondary	FT3	free triiodothyronine in pmol/L	12 months
Secondary	FT4	free thyroxine in pmol/L	12 months
Secondary	FT	free testosterone (nmol/L)	12 months
Secondary	DHEAS	Dehydroepiandrosterone Sulfate (ug/dl)	12 months
Secondary	PTH	parathyroid hormone in (ng / L)	12 months
Secondary	25OHD	25 hydroxyvitamin D in (nmol / L)	12 months
Secondary	Ca	serum calcium in (mmol/L)	12 months
Secondary	GLP-1	Glucagon-like peptide-1(pmol/L)	12 months
Secondary	LCN2	Lipocalin 2 level	12 months
Secondary	Ghrelin	Ghrelin level	12 months
Secondary	Leptin	Leptin level	12 months
Secondary	S100	S100 protein level	12 months
Secondary	GFAP	Glial fibrillary acidic protein level	12 months
Secondary	TEFQ-R21	The 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.	12 months
Secondary	HADS	HADS 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.	12 months