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

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03931434
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.4
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteriosclerosis; Endothelial Dysfunction; Type 2 Diabetes Mellitus	Dietary Supplement: Aged Garlic Extract (AGE); Dietary Supplement: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double Blind Placebo ControlledDouble Blind Placebo Controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus
• Actual Study Start Date: Feb 23, 2016
• Actual Primary Completion Date: May 7, 2018
• Actual Study Completion Date: May 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aged Garlic Extract (AGE) 2400mg of Aged Garlic Extract (AGE)	Dietary Supplement: Aged Garlic Extract (AGE); 2400mg of Aged Garlic Extract (AGE)
Placebo Comparator: Placebo The Placebo does not contain any Aged Garlic Extract (AGE)	Dietary Supplement: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo. [12 months]

   Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.

Secondary Outcome Measures

1. Rate of change in inflammatory biomarkers (CRP,IL-6) [12 months]

   Rate of change in inflammatory biomarkers

2. Rate of change in endothelial function [3 months and 12 months]

   Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center	Torrance	California	United States	90502

Sponsors and Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew J. Budoff, Principal Investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• ClinicalTrials.gov Identifier: NCT03931434
• Other Study ID Numbers: Garlic-5
• First Posted: Apr 30, 2019
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matthew J. Budoff, Principal Investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: coronary artery disease; Endothelium
• Additional relevant MeSH terms: Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 30, 2019