Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Glycocalyx Integrity-Perfused Boundary Region
研究概览
简要总结
The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.
详细描述
Twenty subjects will complete five days of treatment with zanamivir. Baseline measurements will be taken before the initiation of treatment, as well as after the conclusion of the treatment period (i.e., a total of two assessment visits per subject). Assessment visits will include: vitals (such as blood pressure, heart rate), fasting blood work for plasma neuraminidase activity, plasma sialic acid, plasma glucose and plasma insulin, brachial artery FMD, and glycocalyx integrity assessment via Glycocheck.
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
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with a BMI of 25-39 kg/m2
- •Ages 45-64 years at randomization.
- •Diagnosis of T2D classified based on physician diagnosis.
- •No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.
排除标准
- •Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
- •History of chronic renal or hepatic disease
- •Active cancer
- •Autoimmune diseases
- •Immunosuppressant therapy
- •Hormone replacement therapy
- •Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
- •Current tobacco use
- •Pregnancy (Premenopausal women will be required to complete a urine pregnancy test before participation)
- •History of asthma or chronic obstructive pulmonary disease.
- •History of allergic reaction to lactose or milk proteins
- •Intranasal live attenuated influenza vaccine (LAIV) given within 2 weeks before zanamivir administration or a planned dose within 48 hours after zanamivir administration. Product insert states to avoid zanamivir administration with intranasal live attenuated influenza vaccine (LAIV).
研究组 & 干预措施
Zanamivir treatment
Study participants will receive 5 days of treatment with a zanamivir inhaler.
干预措施: Zanamivir (Drug)
结局指标
主要结局
Change in Glycocalyx Integrity-Perfused Boundary Region
时间窗: Day 0 and Day 5
Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity. Outcomes are reported as a change in PBR from Day 0 to Day 5.
次要结局
未报告次要终点
研究者
Luis Martinez-Lemus, DVM, PhD
Professor in Medical Pharmacology Physiology
University of Missouri-Columbia