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

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

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Procedure: Laparoscopic sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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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.,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCOS group<br>Obese Patients with PCOS underwent LSG | Procedure: Laparoscopic sleeve Gastrectomy<br>* Laparoscopic sleeve Gastrectomy<br>|
| Active Comparator: Control group<br>Sample obese patients without PCOS underwent LSG | Procedure: Laparoscopic sleeve Gastrectomy<br>* Laparoscopic sleeve Gastrectomy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, Laparoscopic sleeve gastrectomy, Obesity, menstrual cycle