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

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy (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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Department of Endocrinology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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 female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)	Procedure: laparoscopic sleeve gastrectomy (LSG); 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
Active Comparator: control group; obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)	Procedure: laparoscopic sleeve gastrectomy (LSG); 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Cai M, Gao J, Du L, Cheng X, Zhou D, Zhu J, Qu S, Zhang M. The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up. Obes Surg. 2021 Sep;31(9):4055-4063. doi: 10.1007/s11695-021-05496-6.

Helpful Links

• The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Body fat distribution; Laparoscopic Sleeve Gastrectomy; Visceral adipose tissue; Dual-energy X-ray absorptiometry
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: PCOS DEXA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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