The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Oral glucose tolerance test
研究概览
简要总结
The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hemoglobin A1C between 5.7 and 6.4
- •Body mass index between 27 and 45
排除标准
- •Chronic use of any antidiabetic medications
- •Any unstable medical condition
- •Use of steroids or daily use of NSAIDS
- •History of chronic inflammatory conditions
- •Use of anticoagulants
- •Contraindications to the use of mirabegron or tadalafil
- •Any condition deemed risky by the study physician
研究组 & 干预措施
Mirabegron (M)
Drug will be administered for 12 weeks after baseline procedures.
干预措施: Mirabegron 50 MG (Drug)
Tadalafil (T)
Drug will be administered for 12 weeks after baseline procedures.
干预措施: Tadalafil 10 MG (Drug)
Mirabegron and Tadalafil (MT)
Both drugs will be administered for 12 weeks after baseline procedures.
干预措施: Mirabegron 50 MG (Drug)
Placebo (P)
干预措施: Placebo (Drug)
Mirabegron and Tadalafil (MT)
Both drugs will be administered for 12 weeks after baseline procedures.
干预措施: Tadalafil 10 MG (Drug)
结局指标
主要结局
Oral glucose tolerance test
时间窗: 14 weeks
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
Oral glucose tolerance test
时间窗: Baseline
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
次要结局
- Hemoglobin A1C(14 weeks)
- Hemoglobin A1C(Baseline)
研究者
Philip Kern
Professor
University of Kentucky