Treating Obese PCOS Patients With LSG vs. Met

Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy; Drug: Metformin Pill

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai Tenth People' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic sleeve gastrectomy	Procedure: laparoscopic sleeve gastrectomy; laparoscopic sleeve gastrectomy; Other Names: Sleeve Operation
Active Comparator: Metformin Group	Drug: Metformin Pill; Metformin 1000mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
menstrual cycles	menstrual frequency	3 months
Gonadotropin level	LH(IU/L) , FSH (IU/L),	3 months
testosterone	total testosterone (nmol/L), testosterone (nmol/L)	3 months
SHBG level	SHBG (nmol/L).	3 months
FINS	fasting insulin (IU/L)	3 months
TC	Total cholesterol (mmol/L)	3 months
TG	Triglycerides (mmol/L)	3 months
HDL-c	high-density lipoprotein cholesterol (mmol/L)	3 months
LDL-c	low-density lipoprotein cholesterol (mmol/L)	3 months

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: LSG vs. Met in PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No