NCT05536583

Brief Summary

This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

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, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

7.7 years

First QC Date

September 6, 2022

Last Update Submit

September 29, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromeLaparoscopic sleeve gastrectomyObesitymenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • Menstrual cycles

    the total number of menstrual periods in the last year

    3 years

Secondary Outcomes (29)

  • ZAG

    3 years

  • FGF-19

    3 years

  • FGL-1

    3 years

  • BMI

    3 years

  • Waist/hip Ratio

    3 years

  • +24 more secondary outcomes

Study Arms (2)

PCOS group

EXPERIMENTAL

Obese Patients with PCOS underwent LSG

Procedure: Laparoscopic sleeve Gastrectomy

Control group

ACTIVE COMPARATOR

Sample obese patients without PCOS underwent LSG

Procedure: Laparoscopic sleeve Gastrectomy

Interventions

Laparoscopic sleeve GastrectomyPROCEDURE

Laparoscopic sleeve Gastrectomy

Control groupPCOS group

Eligibility Criteria

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

You may qualify if:

  • age ranged from 18\~45 years old,
  • BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

You may not qualify if:

  • outside of the 18-45 age range;
  • secondary obesity caused by endocrine disorders;
  • history of more than one bariatric procedure;
  • severe hepatic, renal or heart dysfunction;
  • mental illnesses or intellectual disability.
  • pregnancy or lactation
  • contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 13, 2022

Study Start

May 1, 2013

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

October 3, 2022

Record last verified: 2022-09