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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931434
• Other study ID #: Garlic-5
• Status: Completed
• Phase: N/A
• Start date: February 23, 2016
• Est. completion date: May 7, 2018

Study information

• Verified date: April 2019
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endothelial Dysfunction
• Myocardial Ischemia
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of change in inflammatory biomarkers (CRP,IL-6)	Rate of change in inflammatory biomarkers	12 months
Secondary	Rate of change in endothelial function	Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)	3 months and 12 months