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

Primary Purpose

Coronary Arteriosclerosis, Endothelial Dysfunction, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aged Garlic Extract (AGE)
Placebo
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring coronary artery disease, Endothelium

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aged Garlic Extract (AGE)

Placebo

Arm Description

2400mg of Aged Garlic Extract (AGE)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of change in inflammatory biomarkers (CRP,IL-6)
Rate of change in inflammatory biomarkers
Rate of change in endothelial function
Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)

Full Information

First Posted
April 25, 2019
Last Updated
April 29, 2019
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03931434
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2016 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
May 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Endothelial Dysfunction, Type 2 Diabetes Mellitus
Keywords
coronary artery disease, Endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double Blind Placebo Controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aged Garlic Extract (AGE)
Arm Type
Active Comparator
Arm Description
2400mg of Aged Garlic Extract (AGE)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The Placebo does not contain any Aged Garlic Extract (AGE)
Intervention Type
Dietary Supplement
Intervention Name(s)
Aged Garlic Extract (AGE)
Intervention Description
2400mg of Aged Garlic Extract (AGE)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
Description
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of change in inflammatory biomarkers (CRP,IL-6)
Description
Rate of change in inflammatory biomarkers
Time Frame
12 months
Title
Rate of change in endothelial function
Description
Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)
Time Frame
3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

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

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