Clinical trial NCT03931434: Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus
Official title: Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Endothelial Dysfunction
Type 2 Diabetes Mellitus
Keywords: coronary artery disease
Endothelium
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind Placebo Controlled
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
timeFrame: 12 months
Secondary outcomes:
measure: Rate of change in inflammatory biomarkers (CRP,IL-6)
timeFrame: 12 months
measure: Rate of change in endothelial function
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
state: California
Study officials:
References: