Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Change in mean urine osmolality
研究概览
简要总结
The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).
详细描述
Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with a documented mutation in the vasopressin type 2 receptor (V2R)
- •Willing to provide consent and/or assent as appropriate
- •Capable of providing urine samples as dictated by the protocol
排除标准
- •Urinary incontinence
- •Subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than Nephrogenic Diabetes Insipidus (NDI)
- •Subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (GFR) <80 ml/min/1.73 m^2)
- •Subjects with acquired NDI
研究组 & 干预措施
Metformin
Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
干预措施: Metformin (Drug)
结局指标
主要结局
Change in mean urine osmolality
时间窗: Baseline, 7 hours
Urine osmolality is a measure of urine concentration. Urine osmolality will be measured using a Wescor vapor pressure osmometer. A normal range for urine osmolality is approximately 500-850 mOsm/kg water. Change is the difference in average osmolality from baseline to 7 hours.
次要结局
- Change in mean urine volume(Baseline, 7 hours)
研究者
Larry Greenbaum, MD, PhD
Professor
Emory University