Study on Brain Function of Obesity Classification

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Functional Neuroimaging
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Shen Qu, Dr.; Phone Number: (86)021-66301004; Email: qushencn@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Shen Qu, M.D. Ph.D; Phone Number: 86-21-66302531; Email: qushencn@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

120 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MHO group; Metabolic healthy obesity	Procedure: Laparoscopic sleeve gastrectomy; Obese patients of different subtypes were all expected to undergo bariatric surgery
HMO-U group; Hypermetabolic obesity-hyperuricemia	Procedure: Laparoscopic sleeve gastrectomy; Obese patients of different subtypes were all expected to undergo bariatric surgery
HMO-I group; Hypermetabolic obesity-hyperinsulinemia	Procedure: Laparoscopic sleeve gastrectomy; Obese patients of different subtypes were all expected to undergo bariatric surgery
LMO group; Hypometabolic obesity	Procedure: Laparoscopic sleeve gastrectomy; Obese patients of different subtypes were all expected to undergo bariatric surgery
control group; Healthy person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Shen Qu, Dr., Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: obesity; artificial intelligence; Brain; Functional Neuroimaging
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Brain function in obesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No