Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Endothelial function
研究概览
简要总结
This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects
- •Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.
排除标准
- •Women with a positive urine pregnancy test
- •Body mass index >35 kg/m2
- •Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
- •Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
- •Treatment with an investigational drug within the last twelve weeks
- •History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- •Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
- •Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
- •Ongoing illicit drug use or alcohol abuse.
- •Sensitivity/intolerance to dietary polyols.
研究组 & 干预措施
Erythritol
Orange-flavored beverage containing 6, 12, or 18 grams of erythritol
干预措施: Erythritol (Dietary Supplement)
结局指标
主要结局
Endothelial function
时间窗: 2 hours
Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.
次要结局
未报告次要终点