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

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

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCOS group; Obese Patients with PCOS underwent LSG	Procedure: Laparoscopic sleeve Gastrectomy; Laparoscopic sleeve Gastrectomy
Active Comparator: Control group; Sample obese patients without PCOS underwent LSG	Procedure: Laparoscopic sleeve Gastrectomy; Laparoscopic sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual cycles	the total number of menstrual periods in the last year	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ZAG	zinc-alpha2-glycoprotein	3 years
FGF-19	fibroblast growth factor 19	3 years
FGL-1	fibrinogen-like protein 1	3 years
BMI	BMI=weight(kg)/height(m)^2	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
LH	luteinizing hormone in IU/L	3 years
FSH	follicle-stimulating hormone in IU/l	3 years
E2	Estradiol in pmol/L	3 years
PRL	Prolactin in uIU/ml	3 years
CR	Creatinine in umol/L	3 years
AD	Androstenedione in ng/ml	3 years
TC	Total Cholesterol (mmol/L)	3 years
TG	Triglyceride (mmol/L)	3 years

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: menstrual cycle; Obesity; Polycystic ovary syndrome; Laparoscopic sleeve gastrectomy
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome
• Other Study ID Numbers: LSG in PCOS patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No