NCT04690634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

December 20, 2020

Last Update Submit

September 8, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

Laparoscopic Sleeve GastrectomyBody fat distributionDual-energy X-ray absorptiometryVisceral adipose tissue

Outcome Measures

Primary Outcomes (1)

  • VAT mass

    visceral adipose tissue (VAT) mass

    12 months

Secondary Outcomes (25)

  • BMI

    12 months

  • FBG

    12 months

  • PBG

    Baseline and 12 months

  • FINS

    Baseline and 12 months

  • PINS

    Baseline and 12 months

  • +20 more secondary outcomes

Study Arms (2)

PCOS group

EXPERIMENTAL

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

Procedure: laparoscopic sleeve gastrectomy (LSG)

control group

ACTIVE COMPARATOR

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

Procedure: laparoscopic sleeve gastrectomy (LSG)

Interventions

laparoscopic sleeve gastrectomy (LSG)PROCEDURE

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

PCOS groupcontrol group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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;
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Related Publications (1)

  • 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.

    PMID: 34152560BACKGROUND

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Shen Qu, Dr

    Shang hai Tenth People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 31, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)