Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Insulin-stimulated blood flow
研究概览
简要总结
The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.
详细描述
As part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a PS supplement or placebo. Assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (ABPM), Vitals, DEXA scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfPWV), brachial and femoral artery FMDs, Femoral blood flow imaging during passive leg movement (PLM), glycocalyx integrity assessment via Glycocheck, and an oral glucose tolerance test (OGTT) with blood flow measurements and beat-to-beat sphygmomanometry via Finometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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, who are 45-64 years of age at randomization.
- •T2D patients 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
- •Bodyweight change ≥5% within the last 6 months
研究组 & 干预措施
Placebo
Study participants will receive 4 weeks of supplementation with 900mg placebo supplements
干预措施: Placebo (Dietary Supplement)
Phosphatidylserine Supplementation
Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.
干预措施: Phosphatidylserine (Dietary Supplement)
结局指标
主要结局
Change in Insulin-stimulated blood flow
时间窗: baseline and 4 weeks
Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.
Change in Insulin-stimulated Blood Flow
时间窗: baseline and 4 weeks
Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.
次要结局
- Change in Vascular function(Baseline and 4 weeks)
- Percent Change in Vascular Function(Baseline and 4 weeks)
研究者
Luis Martinez-Lemus, DVM, PhD
Professor in Medical Pharmacology Physiology
University of Missouri-Columbia