The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG

Study Overview
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Brief Summary
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Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Abdominal fat accumulation, overweightness and obesity are frequently present in patients with PCOS . Visceral adipose tissue (VAT) plays an important role in the pathogenesis of PCOS.Therefore，this study aim to investigate the changes of body fat distribution in obese women with PCOS after laparoscopic sleeve gastrectomy (LSG), and to explore the factors that may predict the changes in body fat distribution in PCOS patients after LSG.

Detailed Description
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This study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with PCOS and 70 control patients) who underwent LSG from May 2013 to September 2020 at the Department of Endocrinology, Shanghai Tenth People's Hospital, with a 12-month follow-up. Dual-energy X-ray absorptiometry (DEXA) was used to assess body fat distribution.

Official Title
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The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Procedure: laparoscopic sleeve gastrectomy (LSG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fmale aged 18- 45; Meet Rotterdam criteria(2003); body mass index (BMI)≥30 kg/m2 Exclusion Criteria: Gender is male; Younger than 18 years old or older than 45 years old ; secondary obesity due to endocrine disorders; history of malignant tumors; 5）sever hepatic and renal disease; 6) concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCOS group<br>obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG) | Procedure: laparoscopic sleeve gastrectomy (LSG)<br>* Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term<br>|
| Active Comparator: control group<br>obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG) | Procedure: laparoscopic sleeve gastrectomy (LSG)<br>* Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAT mass | visceral adipose tissue (VAT) mass | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body mass index (BMI) was calculated as follows: BMI = (body weight [kg])/(height [m2]) | 12 months | 
| FBG | fasting blood-glucose in mmol/L | 12 months | 
| PBG | postprandial blood-glucose in mmol/L | Baseline and 12 months | 
| FINS | fasting serum insulin in mU/L | Baseline and 12 months | 
| PINS | postprandial insulin in mU/L | Baseline and 12 months | 
| ALT | alanine aminotransferase in U/L | Baseline and 12 months | 
| AST | aspartate aminotransferase in U/L） | Baseline and 12 months | 
| UA | Uric acid in umol/L | Baseline and 12 months | 
| CR | Creatinine in umol/L | Baseline and 12 months | 
| LDL-c | low-density lipoprotein cholesterol in mmol/L | Baseline and 12 months | 
| HDL-c | high-density lipoprotein cholesterol in mmol/L | Baseline and 12 months | 
| TC | Total Cholesterol in mmol/L | Baseline and 12 months | 
| TG | Triglyceride in mmol/L | Baseline and 12 months | 
| WHR | waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference [cm]/(hip circumference [cm]). | Baseline and 12 months | 
| HC | Hip circumference | Baseline and 12 months | 
| Ferriman-Gallwey score | Ferriman-Gallwey score | Baseline and 12 months | 
| Menstrual Cycles | The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months. | Baseline and 12 months | 
| HOMA-IR | homeostatic model assessment insulin resistance index | Baseline and 12 months | 
| TT | total testosterone in nmol/L | Baseline and 12 months | 
| FT | free testosterone (nmol/L) | Baseline and 12 months | 
| DHEAS | Dehydroepiandrosterone Sulfate (ug/dl) | Baseline and 12 months | 
| SHBG | sex hormone-binding globulin in nmol/L | Baseline and 12 months | 
| FSH | follicle-stimulating hormone in IU/L | Baseline and 12 months | 
| LH | luteinizing hormone in IU/L | Baseline and 12 months | 
| WC | waist circumference, | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Sleeve Gastrectomy, Body fat distribution, Dual-energy X-ray absorptiometry, Visceral adipose tissue