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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Procedure: Laparoscopic sleeve Gastrectomy

• Registration Number: NCT05536583
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Laparoscopic sleeve Gastrectomy	Sample obese patients without PCOS underwent LSG
PCOS group	Laparoscopic sleeve Gastrectomy	Obese Patients with PCOS underwent LSG

Primary Outcome Measures

Name	Time	Method
Menstrual cycles	3 years	the total number of menstrual periods in the last year

Secondary Outcome Measures

Name	Time	Method
FGF-19	3 years	fibroblast growth factor 19
FBG	3 years	fasting blood-glucose in mmol/L
AD	3 years	Androstenedione in ng/ml
HOMA-IR	3 years	Homeostatic model assessment insulin resistance index=FBG\*FINS/22.5
HbA1c (%)	3 years	Glycated hemoglobin
FT	3 years	free testosterone (nmol/L)
PRL	3 years	Prolactin in uIU/ml
PINS	3 years	postprandial insulin in mU/L
SHBG	3 years	sex hormone-binding globulin in nmol/L
DHEAS	3 years	Dehydroepiandrosterone Sulfate (ug/dl)
FGL-1	3 years	fibrinogen-like protein 1
BMI	3 years	BMI=weight(kg)/height(m)\^2
PBG	3 years	postprandial blood-glucose in mmol/L
FINS	3 years	fasting serum insulin in mU/L
ALT	3 years	alanine aminotransferase in U/L
UA	3 years	Uric acid in umol/L
LDL-C	3 years	low-density lipoprotein cholesterol in mmol/L
HDL-C	3 years	Hight-density lipoprotein cholesterol in mmol/L
FSH	3 years	follicle-stimulating hormone in IU/l
E2	3 years	Estradiol in pmol/L
ZAG	3 years	zinc-alpha2-glycoprotein
Waist/hip Ratio	3 years	WHR=Waist Circumference in centimeter/Hip Circumference in centimeter
TT	3 years	total testosterone in nmol/L
AST	3 years	aspartate aminotransferase in U/L
LH	3 years	luteinizing hormone in IU/L
TC	3 years	Total Cholesterol (mmol/L)
Fertility	3 years	sexual function, fertility
CR	3 years	Creatinine in umol/L
TG	3 years	Triglyceride (mmol/L)