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

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05536583

Collaborator

(none)

200

Enrollment

Arms

104

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Procedure: Laparoscopic sleeve Gastrectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomyComparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Menstrual cycles [3 years]
the total number of menstrual periods in the last year

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhang Manna, Director, Shanghai 10th People's Hospital

ClinicalTrials.gov Identifier:

NCT05536583

Other Study ID Numbers:

LSG in PCOS

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhang Manna, Director, Shanghai 10th People's Hospital

Polycystic ovary syndrome

Laparoscopic sleeve gastrectomy

Obesity

menstrual cycle

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Study Results

No Results Posted as of Sep 13, 2022