Study on Brain Function of Obesity Classification

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Functional Neuroimaging

Intervention / Treatment
-----------------
* Procedure: Laparoscopic sleeve gastrectomy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MHO group<br>Metabolic healthy obesity | Procedure: Laparoscopic sleeve gastrectomy<br>* Obese patients of different subtypes were all expected to undergo bariatric surgery<br>|
| HMO-U group<br>Hypermetabolic obesity-hyperuricemia | Procedure: Laparoscopic sleeve gastrectomy<br>* Obese patients of different subtypes were all expected to undergo bariatric surgery<br>|
| HMO-I group<br>Hypermetabolic obesity-hyperinsulinemia | Procedure: Laparoscopic sleeve gastrectomy<br>* Obese patients of different subtypes were all expected to undergo bariatric surgery<br>|
| LMO group<br>Hypometabolic obesity | Procedure: Laparoscopic sleeve gastrectomy<br>* Obese patients of different subtypes were all expected to undergo bariatric surgery<br>|
| control group<br>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 |
| --- | --- | --- |
| 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 | 
| FBG | fasting blood-glucose in mmol/L | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, Functional Neuroimaging, Brain, artificial intelligence