Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

Shanghai 10th People's Hospital200 enrolled

Overview

This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.

This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled. All PCOS 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 were measured baseline and postoperative.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Polycystic Ovary Syndrome

Interventions

Laparoscopic sleeve GastrectomyPROCEDURE

Laparoscopic sleeve Gastrectomy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ranged from 18\~45 years old, * 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: * outside of the 18-45 age range; * secondary obesity caused by endocrine disorders; * history of more than one bariatric procedure; * severe hepatic, renal or heart dysfunction; * mental illnesses or intellectual disability. * pregnancy or lactation * contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,

Outcomes

Primary Outcomes

Menstrual cycles

the total number of menstrual periods in the last year

Time frame: 3 years

Secondary Outcomes

ZAG

zinc-alpha2-glycoprotein

Time frame: 3 years

FGF-19

fibroblast growth factor 19

Time frame: 3 years

FGL-1

fibrinogen-like protein 1

Time frame: 3 years

BMI

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

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

Data from ClinicalTrials.gov

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