Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
研究概览
简要总结
The purpose of this research study is to see the effect of taking Aged Garlic Extract (AGE) on the progression of coronary plaque, a condition called atherosclerosis, in people diagnosed with Diabetes.
详细描述
This clinical trial is to determine on progression rates of low attenuation plaque under influence of Aged Garlic Extract as compared to placebo over the 1year period in individuals with Type 2 Diabetes Mellitus.The study also examines the effect of Aged Garlic Extract on endothelial function and arterial stiffness which was measured by cardio-ankle vascular index (CAVI) over the 3months period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-75 years
- •Known Diabetes Mellitus (HgA1c >6.5%, fasting blood sugar >125 mg/dl, taking anti- diabetes medications)
- •Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
- •Calcium Score >20 at baseline
排除标准
- •A contraindication to AGE including: known hypersensitivity to drug.
- •Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- •Weight in excess of 350 pounds
- •Bleeding disorder
- •History of known coronary artery disease, myocardial infarction, stroke or life- threatening arrhythmia within the prior six months
- •NYHA Class II- IV heart failure
- •History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
- •Serum creatinine > 1.4 mg/dl
- •Triglycerides > 400 at visit 1
- •Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- •Concurrent enrollment in another placebo-controlled trial
- •Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- •Current tobacco use
- •Current use of anticoagulants (except for anti-platelet agents)
- •Renal failure
- •History of hypertensive encephalopathy or cerebrovascular accident
- •Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
- •Pregnancy
研究组 & 干预措施
Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
干预措施: Aged Garlic Extract (AGE) (Dietary Supplement)
Placebo
The Placebo does not contain any Aged Garlic Extract (AGE)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
时间窗: 12 months
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
次要结局
- Rate of change in inflammatory biomarkers (CRP,IL-6)(12 months)
- Rate of change in endothelial function(3 months and 12 months)
研究者
Matthew J. Budoff
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center