NCT04508634

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. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

August 7, 2020

Last Update Submit

April 10, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

  • HOMA-IR

    Insulin resistance index

    3 months

  • Screening of metabolites in plasma concentration in fasting condition

    The investigators will perform metabolites to identify the changes that may give rise to the disease.

    3 months

  • Screening of transcriptome profile in plasma concentration in fasting condition

    The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.

    3 months

  • Screening of Microbiome in faeces

    The investigators will perform Microbiome to identify the changes that may give rise to the disease.

    3 months

Secondary Outcomes (9)

  • menstrual cycles

    3 months

  • Gonadotropin level

    3 months

  • testosterone

    3 months

  • SHBG level

    3 months

  • FINS

    3 months

  • +4 more secondary outcomes

Study Arms (2)

laparoscopic sleeve gastrectomy

EXPERIMENTAL

laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

Metformin Group

ACTIVE COMPARATOR

Metformin Group

Drug: Metformin Pill

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

laparoscopic sleeve gastrectomy

Also known as: Sleeve Operation
laparoscopic sleeve gastrectomy
Metformin PillDRUG

Metformin 1000mg bid

Metformin Group

Eligibility Criteria

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

You may qualify if:

  • female aged 18- 45;
  • meet Rotterdam criteria;
  • BMI ≥ 28 kg /m2.

You may not qualify if:

  • Women who are pregnant or have a pregnancy plan within six months;
  • Women who are reluctant to undergo metabolic surgery;
  • Congenital adrenocortical hyperplasia;
  • Hyperprolactinemia;
  • Hyperthyroidism or hypothyroidism;
  • Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR\<60ml/min/1.73m2);
  • Adrenal or ovarian tumors secreting androgens;
  • Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Shen Qu, Dr

    Shang hai Tenth People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: laparoscopic sleeve gastrectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Endocrinology & Metabolism

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

November 1, 2020

Primary Completion

September 1, 2024

Study Completion

September 30, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)