Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome was change in fasting concentration of glucose.
研究概览
简要总结
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old to menopause
- •polycystic ovary syndrome (NICHD criteria)
- •BMI of 30 kg/m² or higher
排除标准
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •personal or family history of MEN 2
- •significant cardiovascular, kidney or hepatic disease
研究组 & 干预措施
metformin and alogliptin
Vipdomet 12.5 mg/1000 mg tablets
干预措施: Vipdomet (Drug)
pioglitasone and alogliptin
Incresync 12,5 mg/30 mg tablets
干预措施: Incresync (Drug)
结局指标
主要结局
Primary outcome was change in fasting concentration of glucose.
时间窗: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
时间窗: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.
Primary outcome was change in beta cell function using adaptation index.
时间窗: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.
Primary outcome was change in fasting concentration of insulin.
时间窗: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.
次要结局
- Secondary outcome was change in body mass index (BMI).(Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint)
研究者
Andrej Janez
Andrej Janez, MD, PhD
University Medical Centre Ljubljana