Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18 years to 40 years of age
- •Diagnosed as PCOS by the 2003 Rotterdam criteria.
- •Overweight/obesity (BMI≥25 kg/m2)
- •No pregnant plan in recent 6 months
- •Written consent for participation in the study
排除标准
- •type 1 or type 2 diabetes mellitus
- •Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
- •Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- •Serious systemic disease or malignant tumor
- •History of pancreatitis (chronic, acute or recurrent)
- •Body weight change ≥10% at 3 months before treatment
- •Used oral contraceptives or sex hormone drugs in the past 1 month
- •Used oral glucocorticoids in the past 1 month
- •Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
- •Subjects have a severe systemic disease, such as cardiovascular system
- •Renal impairment, eGFR<60ml/min/1.73m2
- •Increase of transaminases up to < 2.5 times of upper limit of normal value
- •Have a history of thromboembolic disease or thrombotic tendency
- •Subjects in pregnant or lactating or within 1 year after delivery.
- •Subjects have an allergic history to the drugs used in the study
- •Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
- •Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.
研究组 & 干预措施
Metformin
Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)
Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.
干预措施: Metformin (Drug)
Metformin+EQW
Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)
Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.
EQW: Participants will receive long-acting Exenatide once a week for 12 weeks
干预措施: Metformin (Drug)
Metformin+EQW
Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)
Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.
EQW: Participants will receive long-acting Exenatide once a week for 12 weeks
干预措施: Exenatide 2 MG (Drug)
结局指标
主要结局
Change in body weight
时间窗: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
次要结局
- Proportion of subjects who lost ≥5% of their body weight(12 weeks)
- Proportion of subjects who lost ≥ 10% of their body weight(12 weeks)
- Change in body mass index (BMI)(12 weeks)
- Change in waist circumference(WC)(12 weeks)
- Change in hip circumference (HC)(12 weeks)
- Changes in lipid accumulation product(LAP)(12 weeks)
- Changes in Visceral obesity index(VAI)(12 weeks)
- Changes in blood pressure(12 weeks)
- Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)(12 weeks)
- Changes in total cholesterol (TC)(12 weeks)
- Changes in serum triglyceride (TG)(12 weeks)
- Changes in high-density lipoproteincholesterol (HDL-C)(12 weeks)
- Changes in low-density lipoproteincholesterol (LDL-C)(12 weeks)
- Changes in lipoprotein(a)(12 weeks)
- Changes in apolipoprotein a1(ApoA1)(12 weeks)
- Changes in apolipoprotein B(ApoB)(12 weeks)
- Changes in free fatty acid (FFA)(12 weeks)
- Changes in high sensitivity C reactive protein(hsCRP)(12 weeks)
- Frequency of menstrual cycle(12 weeks)
- Changes in testosterone(12 weeks)
- Changes in Dehydroepiandrosterone sulfate (DHEAS)(12 weeks)
- Changes in Luteinizing Hormone (LH)(12 weeks)
- Changes in follicle stimulating hormone(FSH)(12 weeks)
- Changes in LH/FSH(12 weeks)
- Changes in Acne severity score(12 weeks)
- Changes in ovarian volume(12 weeks)
- Changes in follicular number of 2-9mm in diameter(12 weeks)
研究者
Aijun Sun
Professor
Peking Union Medical College Hospital