Phase 3 Randomized Trial of Tadalafil and Glycemic Traits
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR
研究概览
简要总结
The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).
详细描述
This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.
The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.
The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years and < 50 years
- •BMI > 30 kg/m2
- •Fasting insulin > 10 uU/mL
排除标准
- •Systolic blood pressure (SBP) < 100, > 150 mmHg
- •Current anti-hypertensive medication use, including diuretics
- •Current use of organic nitrates
- •Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
- •History of reaction to PDE-5 inhibitors
- •Known HIV infection
- •Use of medications that strongly alter CYP3A4 activity
- •History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
- •Known non-arteritic ischemic optic retinopathy (NAIOR)
- •History of hearing loss
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
- •Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
- •Known pregnancy or those unwilling to avoid pregnancy during the course of the study
- •History of priapism
- •Use in excess of four alcoholic drinks daily
- •History of diabetes mellitus or use of anti-diabetic medications
- •Known anemia (men, Hct < 38% and women, Hct < 36%)
研究组 & 干预措施
Tadalafil
20 mg Tadalafil tablet taken by mouth once a day for 3 months
干预措施: Tadalafil (Drug)
Placebo
Placebo tablet taken by mouth once a day for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR
时间窗: Baseline and 3 months
The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \[fasting glucose \* fasting insulin\]/405
次要结局
- Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index(Baseline and 3 months)
- Baseline to 3-month Change in Endothelial Function Measured by EndoPAT(Baseline and 3 months)
- Insulinogenic Index(Baseline and 3 months)
- Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index(Baseline and 3 months)
- Baseline to 3-month Change in Matsuda Disposition Index(Baseline and 3 months)
研究者
Thomas J. Wang, MD
Associate Professor of Medicine, Harvard Medical School
Massachusetts General Hospital