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出境医 / 临床实验 / Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus
Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus
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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double 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 : | February 23, 2016 |
| Actual Primary Completion Date : | May 7, 2018 |
| Actual Study Completion Date : | May 7, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
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Dietary Supplement: Aged Garlic Extract (AGE)
2400mg of Aged Garlic Extract (AGE)
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Placebo Comparator: Placebo
The Placebo does not contain any Aged Garlic Extract (AGE)
|
Dietary Supplement: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures :
- Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo. [ Time Frame: 12 months ]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) [ Time Frame: 12 months ]Rate of change in inflammatory biomarkers
- Rate of change in endothelial function [ Time Frame: 3 months and 12 months ]Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Locations
| United States, California | |
| 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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||
| First Posted Date ICMJE | April 30, 2019 | ||||
| Last Update Posted Date | April 30, 2019 | ||||
| Actual Study Start Date ICMJE | February 23, 2016 | ||||
| Actual Primary Completion Date | May 7, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo. [ Time Frame: 12 months ] Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus | ||||
| Official Title ICMJE | Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double Blind Placebo Controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
88 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 7, 2018 | ||||
| Actual Primary Completion Date | May 7, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 30 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03931434 | ||||
| Other Study ID Numbers ICMJE | Garlic-5 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
| Study Sponsor ICMJE | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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