Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- HOMA-IR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female aged 18- 45;
- •meet Rotterdam criteria;
- •BMI ≥ 28 kg /m2.
排除标准
- •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.
研究组 & 干预措施
laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy
干预措施: laparoscopic sleeve gastrectomy (Procedure)
Metformin Group
Metformin Group
干预措施: Metformin Pill (Drug)
结局指标
主要结局
HOMA-IR
时间窗: 3 months
Insulin resistance index
Screening of metabolites in plasma concentration in fasting condition
时间窗: 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
时间窗: 3 months
The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.
Screening of Microbiome in faeces
时间窗: 3 months
The investigators will perform Microbiome to identify the changes that may give rise to the disease.
次要结局
- SHBG level(3 months)
- testosterone(3 months)
- FINS(3 months)
- TC(3 months)
- menstrual cycles(3 months)
- Gonadotropin level(3 months)
- TG(3 months)
- HDL-c(3 months)
- LDL-c(3 months)
研究者
Zhang Manna
Department of Endocrinology & Metabolism
Shanghai 10th People's Hospital