Treating Obese PCOS Patients With LSG vs. Met

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-09-30

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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

laparoscopic sleeve gastrectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic sleeve gastrectomy

Group Type EXPERIMENTAL

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

laparoscopic sleeve gastrectomy

Metformin Group

Group Type ACTIVE_COMPARATOR

Metformin Pill

Intervention Type DRUG

Metformin 1000mg bid

Interventions

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laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Metformin Pill

Metformin 1000mg bid

Intervention Type DRUG

Other Intervention Names

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Sleeve Operation

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No