Effect of Aged Garlic Extract on Atherosclerosis
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | May 2012 |
| End Date: | August 2013 |
| Contact: | Matthew Budoff, MD |
| Email: | mbudoff@labiomed.org |
| Phone: | 3102224107 |
The investigators will be assessing the effect of Aged Garlic Extract on the coronary
arteries. The investigators will enroll patients in a double blind study, where half the
patients will receive placebo, and have the patients undergo a series of tests of plaque (CT
scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and
then repeat the tests and blood work at the end of one year. The investigators will assess
if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries.
The investigators will also assess the effect of aged garlic extract on markers of
inflammation. Patients will receive free drug, free testing and be compensated, and learn
more about their heart and neck arteries. if successful, more patients can use this drug to
benefit their health. The harms include the radiation from the CT scan and the medication,
which has mild side effects.
arteries. The investigators will enroll patients in a double blind study, where half the
patients will receive placebo, and have the patients undergo a series of tests of plaque (CT
scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and
then repeat the tests and blood work at the end of one year. The investigators will assess
if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries.
The investigators will also assess the effect of aged garlic extract on markers of
inflammation. Patients will receive free drug, free testing and be compensated, and learn
more about their heart and neck arteries. if successful, more patients can use this drug to
benefit their health. The harms include the radiation from the CT scan and the medication,
which has mild side effects.
Inclusion Criteria
- Age 40-65 years
- Framingham risk score 6-20%, and at least 2 components of the metabolic syndrome as
defined by ATP III Clinical Identification of the Metabolic Syndrome (including
impaired fasting glucose > 110 mg/dl, treated hypertension or SBP > 130 or DBP > 85
mm Hg, plasma triglycerides > 150 mg/dl, HDL cholesterol < 35 mg/dl for men or < 40
mg/dl for women, abdominal obesity as defined as waist > 40 in for men, > 35 in for
women)
- Subjects must provide written informed consent after the scope and nature of the
investigation has been explained to them
- Subjects should be stable on their concomitant medications for at least 26 weeks
prior to randomization
- Calcium Score > 20 at baseline
- Subjects who agree to refrain from other anti-glycemic agent 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 300 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
- Diabetes Mellitus
- 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 diabetes or intaking of anti-diabetic or other prohibited drug
- 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
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