NCT03931434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

April 25, 2019

Last Update Submit

April 29, 2019

Conditions

Coronary ArteriosclerosisEndothelial DysfunctionType 2 Diabetes Mellitus

Keywords

coronary artery diseaseEndothelium

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Rate of change in inflammatory biomarkers (CRP,IL-6)

    12 months

  • Rate of change in endothelial function

    3 months and 12 months

Study Arms (2)

Aged Garlic Extract (AGE)

ACTIVE COMPARATOR

2400mg of Aged Garlic Extract (AGE)

Dietary Supplement: Aged Garlic Extract (AGE)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Aged Garlic Extract (AGE)DIETARY_SUPPLEMENT

2400mg of Aged Garlic Extract (AGE)

Aged Garlic Extract (AGE)
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double Blind Placebo Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

February 23, 2016

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

US(1)