Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Assessment of Reproductive Functions
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.
详细描述
Groups:
Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.
Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.
Time Point:
Initial treatment;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
- •Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
- •Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].
- •All subjects had normal thyroid-stimulating hormone and prolactin levels.
排除标准
- •smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
- •age below 18 yr or over 50 yr.
- •postmenopausal.
- •uncontrolled hypertension (blood pressure >=160/100 mm Hg).
- •preexisting OPs or GLP-1 agonists supplementation
- •alcohol intake greater than 20 g/d, or pregnancy.
- •signs of liver or renal failure or active liver disease (ALT > 2.5× the upper limit of normal values).
- •PLT<60*10^9/L,Hb<100g/L, smoking, alcohol use.
- •The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.
研究组 & 干预措施
Metformin-GLP-1 Receptor Agonist
Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.
干预措施: Metformin-GLP-1 Receptor Agonist (Drug)
Metformin-Oral Contraceptive(OC)
Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.
干预措施: Metformin-Oral Contraceptive(OC) (Drug)
结局指标
主要结局
Assessment of Reproductive Functions
时间窗: 12 weeks
Concentration of LH was measured in mIU/ml.
次要结局
- Basic Vital Signs(12 weeks)
- Assessment of Liver Function(12 weeks)
- Assessment of Blood Pressure(12 weeks)
- Assessment of Reproductive Function(12 weeks)
研究者
Long Min,MD
Deputy Chief Physician, Associated professor
Xinqiao Hospital of Chongqing