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

NCT ID: NCT03931434

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2018-05-07

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.

Conditions

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Coronary Arteriosclerosis Endothelial Dysfunction Type 2 Diabetes Mellitus

Keywords

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coronary artery disease Endothelium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Placebo Controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aged Garlic Extract (AGE)

2400mg of Aged Garlic Extract (AGE)

Group Type ACTIVE_COMPARATOR

Aged Garlic Extract (AGE)

Intervention Type DIETARY_SUPPLEMENT

2400mg of Aged Garlic Extract (AGE)

Placebo

The Placebo does not contain any Aged Garlic Extract (AGE)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Aged Garlic Extract (AGE)

2400mg of Aged Garlic Extract (AGE)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Matthew J. Budoff

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, United States

Site Status

Countries

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United States

Other Identifiers

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Garlic-5

Identifier Type: -

Identifier Source: org_study_id