Treating Obese PCOS Patients With LSG vs. Met

Phase 4

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin Pill; Procedure: laparoscopic sleeve gastrectomy

• Registration Number: NCT04508634
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Study Start: 2020-11-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin Group	Metformin Pill	Metformin Group
laparoscopic sleeve gastrectomy	laparoscopic sleeve gastrectomy	laparoscopic sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
HOMA-IR	3 months	Insulin resistance index
Screening of metabolites in plasma concentration in fasting condition	3 months	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	3 months	The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.
Screening of Microbiome in faeces	3 months	The investigators will perform Microbiome to identify the changes that may give rise to the disease.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Tenth People' Hospital; 🇨🇳 Shanghai, Shanghai, China