Pilot Study of The Effects of Tauroursodeoxycholic Acid (TUDCA) on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in vascular function
研究概览
简要总结
The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.
详细描述
This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial function.All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period. The study will consist of four visits (screening visit and three study visits), and last up to 2 weeks for individual subjects, depending on the time between visits. It is estimated that the study will last two years from IRB approval through data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus defined as fasting glucose greater than or equal to 120 mg/dL, HgA1C ≥6.5% or ongoing treatment with hypoglycemic medication.
- •Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
排除标准
- •Women lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
- •Treatment with an investigational product within the last 30 days.
- •Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
- •Inability to provide informed consent.
- •Clinical instability that would preclude withholding medications as determined by the study physician.
研究组 & 干预措施
TUDCA Group
All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period of of the nutritional supplement Tauroursodeoxycholic acid (TUDCA).
干预措施: Tauroursodeoxycholic acid (Dietary Supplement)
结局指标
主要结局
Change in vascular function
时间窗: before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period
Endothelium -dependent flow-mediated dilation of the brachial artery by ultrasound and fingertip tonometry at baseline and 5-minute cuff occlusion of the upper arm.
次要结局
- Change in endoplasmic reticulum stress(before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period)
- Change in fasting glucose(before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period)
- Change in endothelial function(before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period)
- Change in insulin levels(before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period)
- Change in lipid levels(before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period)