Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus

Conditions
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Coronary Arteriosclerosis, Endothelial Dysfunction, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Aged Garlic Extract (AGE)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind Placebo Controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aged Garlic Extract (AGE)<br>2400mg of Aged Garlic Extract (AGE) | Dietary Supplement: Aged Garlic Extract (AGE)<br>* 2400mg of Aged Garlic Extract (AGE)<br>|
| Placebo Comparator: Placebo<br>The Placebo does not contain any Aged Garlic Extract (AGE) | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo. | Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in inflammatory biomarkers (CRP,IL-6) | Rate of change in inflammatory biomarkers | 12 months | 
| Rate of change in endothelial function | Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI) | 3 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, Endothelium