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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Procedure: laparoscopic sleeve gastrectomy (LSG)

• Registration Number: NCT04690634
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-31
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

1. Fmale aged 18- 45;
2. Meet Rotterdam criteria(2003);
3. body mass index (BMI)≥30 kg/m2

Exclusion Criteria

1. Gender is male;
2. Younger than 18 years old or older than 45 years old ;
3. secondary obesity due to endocrine disorders;
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	laparoscopic sleeve gastrectomy (LSG)	obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)
PCOS group	laparoscopic sleeve gastrectomy (LSG)	obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)

Primary Outcome Measures

Name	Time	Method
VAT mass	12 months	visceral adipose tissue (VAT) mass

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China