Treating Obese PCOS Patients With LSG vs. Met

Shanghai 10th People's Hospital90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

laparoscopic sleeve gastrectomy

Metformin PillDRUG

Metformin 1000mg bid

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

HOMA-IR

Insulin resistance index

Time frame: 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.

Time frame: 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.

Time frame: 3 months

Screening of Microbiome in faeces

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

Time frame: 3 months

Secondary Outcomes

menstrual cycles

menstrual frequency

Time frame: 3 months

Gonadotropin level

LH(IU/L) , FSH (IU/L),

Time frame: 3 months

testosterone

total testosterone (nmol/L), testosterone (nmol/L)

Time frame: 3 months

SHBG level

SHBG (nmol/L).

Time frame: 3 months

FINS

fasting insulin (IU/L)

Data from ClinicalTrials.gov

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