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Treating Obese PCOS Patients With LSG vs. Met

Primary Purpose

Polycystic Ovary Syndrome

Status
Enrolling by invitation
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
Metformin Pill
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

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Shanghai Tenth People' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laparoscopic sleeve gastrectomy

Metformin Group

Arm Description

laparoscopic sleeve gastrectomy

Metformin Group

Outcomes

Primary Outcome Measures

HOMA-IR
Insulin resistance index
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.
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.
Screening of Microbiome in faeces
The investigators will perform Microbiome to identify the changes that may give rise to the disease.

Secondary Outcome Measures

menstrual cycles
menstrual frequency
Gonadotropin level
LH(IU/L) , FSH (IU/L),
testosterone
total testosterone (nmol/L), testosterone (nmol/L)
SHBG level
SHBG (nmol/L).
FINS
fasting insulin (IU/L)
TC
Total cholesterol (mmol/L)
TG
Triglycerides (mmol/L)
HDL-c
high-density lipoprotein cholesterol (mmol/L)
LDL-c
low-density lipoprotein cholesterol (mmol/L)

Full Information

First Posted
August 7, 2020
Last Updated
April 10, 2023
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04508634
Brief Title
Treating Obese PCOS Patients With LSG vs. Met
Official Title
Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
laparoscopic sleeve gastrectomy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic sleeve gastrectomy
Arm Type
Experimental
Arm Description
laparoscopic sleeve gastrectomy
Arm Title
Metformin Group
Arm Type
Active Comparator
Arm Description
Metformin Group
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Other Intervention Name(s)
Sleeve Operation
Intervention Description
laparoscopic sleeve gastrectomy
Intervention Type
Drug
Intervention Name(s)
Metformin Pill
Intervention Description
Metformin 1000mg bid
Primary Outcome Measure Information:
Title
HOMA-IR
Description
Insulin resistance index
Time Frame
3 months
Title
Screening of metabolites in plasma concentration in fasting condition
Description
The investigators will perform metabolites to identify the changes that may give rise to the disease.
Time Frame
3 months
Title
Screening of transcriptome profile in plasma concentration in fasting condition
Description
The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.
Time Frame
3 months
Title
Screening of Microbiome in faeces
Description
The investigators will perform Microbiome to identify the changes that may give rise to the disease.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
menstrual cycles
Description
menstrual frequency
Time Frame
3 months
Title
Gonadotropin level
Description
LH(IU/L) , FSH (IU/L),
Time Frame
3 months
Title
testosterone
Description
total testosterone (nmol/L), testosterone (nmol/L)
Time Frame
3 months
Title
SHBG level
Description
SHBG (nmol/L).
Time Frame
3 months
Title
FINS
Description
fasting insulin (IU/L)
Time Frame
3 months
Title
TC
Description
Total cholesterol (mmol/L)
Time Frame
3 months
Title
TG
Description
Triglycerides (mmol/L)
Time Frame
3 months
Title
HDL-c
Description
high-density lipoprotein cholesterol (mmol/L)
Time Frame
3 months
Title
LDL-c
Description
low-density lipoprotein cholesterol (mmol/L)
Time Frame
3 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: female aged 18- 45; meet Rotterdam criteria; BMI ≥ 28 kg /m2. Exclusion Criteria: 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.
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
Shanghai Tenth People' Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Obese PCOS Patients With LSG vs. Met

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