Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients

Study Overview
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Brief Summary
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This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.

Detailed Description
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This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 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, 12, 24, and 36 months after 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.

Official Title
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Shanghai Tenth People's Hospital，School of Medicine, Tongji University

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) age ranged from 16 65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. - Exclusion Criteria: 1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG in obese<br>Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications | Procedure: Laparoscopic sleeve gastrectomy<br>* bariatric surgery<br>|
| Control group<br>healthy individuals with normal BMI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic steatosis | hepatic steatosis assessed by FibroScan(CAP value and E value) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI=weight(kg)/height(m)^2 | 3 years | 
| Menstrual cycles | the total number of menstrual periods in the last year | 3 years | 
| Waist/hip Ratio | WHR=Waist Circumference in centimeter/Hip Circumference in centimeter | 3 years | 
| TT | total testosterone in nmol/L | 3 years | 
| FBG | fasting blood-glucose in mmol/L | 3 years | 
| PBG | postprandial blood-glucose in mmol/L | 3 years | 
| FINS | fasting serum insulin in mU/L | 3 years | 
| PINS | postprandial insulin in mU/L | 3 years | 
| ALT | alanine aminotransferase in U/L | 3 years | 
| AST | aspartate aminotransferase in U/L | 3 years | 
| UA | Uric acid in umol/L | 3 years | 
| HOMA-IR | Homeostatic model assessment insulin resistance index=FBG*FINS/22.5 | 3 years | 
| HbA1c (%)， | Glycated hemoglobin | 3 years | 
| SHBG | sex hormone-binding globulin in nmol/L | 3 years | 
| FT | free testosterone (nmol/L) | 3 years | 
| DHEAS | Dehydroepiandrosterone Sulfate (ug/dl) | 3 years | 
| LDL-C | low-density lipoprotein cholesterol in mmol/L、 | 3 years | 
| HDL-C | Hight-density lipoprotein cholesterol in mmol/L、 | 3 years | 
| Fertility | sexual function, fertility | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic sleeve Gastrectomy, Nonalcoholic Fatty Liver, Type 2 Diabetes, Polycystic Ovary Syndrome, Acanthosis nigricans, Hyperuricemia, Hyperinsulinemia, Sleep apnea Syndrome