Inkretineffekten Hos Patienter Med Polycystisk Ovariesyndrom før og Efter Behandling af Insulinresistens (Incretin Effect in Patients With Polycystic Ovary Syndrome Before and After Treatment of Insulin Resistance)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The change in incretin effect from baseline and until after removal of insulin resistance
研究概览
简要总结
This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin.
The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin-Placebo
Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
干预措施: Metformin (Drug)
Metformin-Placebo
Metformin, 2x 2 tablets a day, 500 mg tablets for 12 weeks, 6 weeks wash-out, 12 weeks placebo
干预措施: Placebo (Drug)
Placebo-metformin
Placebo tablets, 2x 2 tablets per day for 12 weeks, 6 weeks wash-out, 12 weeks metformin, 2x 2 tablets per day, 500 mg per tablet
干预措施: Metformin (Drug)
Placebo-metformin
Placebo tablets, 2x 2 tablets per day for 12 weeks, 6 weeks wash-out, 12 weeks metformin, 2x 2 tablets per day, 500 mg per tablet
干预措施: Placebo (Drug)
结局指标
主要结局
The change in incretin effect from baseline and until after removal of insulin resistance
时间窗: baseline and 12 weeks' treatment
The incretin effect will be assessed from the insulin secretion during af 75 g OGTT and IIGI at baseline and after 12 weeks' treatment with placebo and metformin
次要结局
- Glucagon response(0, 12 and 30 weeks)
研究者
Louise Vedtofte
Humanbiolog, ph.d.
University Hospital, Gentofte, Copenhagen