Treating Obese PCOS Patients With LSG vs. Met

Study Overview
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Brief Summary
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Procedure: laparoscopic sleeve gastrectomy
* Drug: Metformin Pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: laparoscopic sleeve gastrectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic sleeve gastrectomy<br>laparoscopic sleeve gastrectomy | Procedure: laparoscopic sleeve gastrectomy<br>* laparoscopic sleeve gastrectomy<br>* Other names: Sleeve Operation;|
| Active Comparator: Metformin Group<br>Metformin Group | Drug: Metformin Pill<br>* Metformin 1000mg bid<br>|

What is the study measuring?
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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 |