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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy (LSG)
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Laparoscopic Sleeve Gastrectomy, Body fat distribution, Dual-energy X-ray absorptiometry, Visceral adipose tissue

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Endocrinology, Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCOS group

control group

Arm Description

obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)

obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)

Outcomes

Primary Outcome Measures

VAT mass
visceral adipose tissue (VAT) mass

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2020
Last Updated
September 8, 2022
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04690634
Brief Title
The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG
Official Title
The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Laparoscopic Sleeve Gastrectomy, Body fat distribution, Dual-energy X-ray absorptiometry, Visceral adipose tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCOS group
Arm Type
Experimental
Arm Description
obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy (LSG)
Intervention Description
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
Primary Outcome Measure Information:
Title
VAT mass
Description
visceral adipose tissue (VAT) mass
Time Frame
12 months
Secondary Outcome Measure Information:
Title
BMI
Description
Body mass index (BMI) was calculated as follows: BMI = (body weight [kg])/(height [m2])
Time Frame
12 months
Title
FBG
Description
fasting blood-glucose in mmol/L
Time Frame
12 months
Title
PBG
Description
postprandial blood-glucose in mmol/L
Time Frame
Baseline and 12 months
Title
FINS
Description
fasting serum insulin in mU/L
Time Frame
Baseline and 12 months
Title
PINS
Description
postprandial insulin in mU/L
Time Frame
Baseline and 12 months
Title
ALT
Description
alanine aminotransferase in U/L
Time Frame
Baseline and 12 months
Title
AST
Description
aspartate aminotransferase in U/L）
Time Frame
Baseline and 12 months
Title
UA
Description
Uric acid in umol/L
Time Frame
Baseline and 12 months
Title
CR
Description
Creatinine in umol/L
Time Frame
Baseline and 12 months
Title
LDL-c
Description
low-density lipoprotein cholesterol in mmol/L
Time Frame
Baseline and 12 months
Title
HDL-c
Description
high-density lipoprotein cholesterol in mmol/L
Time Frame
Baseline and 12 months
Title
TC
Description
Total Cholesterol in mmol/L
Time Frame
Baseline and 12 months
Title
TG
Description
Triglyceride in mmol/L
Time Frame
Baseline and 12 months
Title
WHR
Description
waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference [cm]/(hip circumference [cm]).
Time Frame
Baseline and 12 months
Title
HC
Description
Hip circumference
Time Frame
Baseline and 12 months
Title
Ferriman-Gallwey score
Description
Ferriman-Gallwey score
Time Frame
Baseline and 12 months
Title
Menstrual Cycles
Description
The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months.
Time Frame
Baseline and 12 months
Title
HOMA-IR
Description
homeostatic model assessment insulin resistance index
Time Frame
Baseline and 12 months
Title
TT
Description
total testosterone in nmol/L
Time Frame
Baseline and 12 months
Title
FT
Description
free testosterone (nmol/L)
Time Frame
Baseline and 12 months
Title
DHEAS
Description
Dehydroepiandrosterone Sulfate (ug/dl)
Time Frame
Baseline and 12 months
Title
SHBG
Description
sex hormone-binding globulin in nmol/L
Time Frame
Baseline and 12 months
Title
FSH
Description
follicle-stimulating hormone in IU/L
Time Frame
Baseline and 12 months
Title
LH
Description
luteinizing hormone in IU/L
Time Frame
Baseline and 12 months
Title
WC
Description
waist circumference,
Time Frame
Baseline and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, Dr
Organizational Affiliation
Shang hai Tenth People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200070
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34152560
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34152560/
Description
The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up

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

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