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

Shanghai 10th People's Hospital300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Obesity

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

bariatric surgery

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hepatic steatosis

hepatic steatosis assessed by FibroScan(CAP value and E value)

Time frame: 3 years

Secondary Outcomes

BMI

BMI=weight(kg)/height(m)\^2

Time frame: 3 years

Menstrual cycles

the total number of menstrual periods in the last year

Time frame: 3 years

Waist/hip Ratio

WHR=Waist Circumference in centimeter/Hip Circumference in centimeter

Time frame: 3 years

total testosterone in nmol/L

Time frame: 3 years

FBG

fasting blood-glucose in mmol/L

Time frame: 3 years

PBG

postprandial blood-glucose in mmol/L

Time frame: 3 years

FINS

fasting serum insulin in mU/L

Time frame: 3 years

PINS

postprandial insulin in mU/L

Time frame: 3 years

ALT

alanine aminotransferase in U/L

Time frame: 3 years

Data from ClinicalTrials.gov

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