Effect of Probiotic Supplementation on Endothelial Function II

Effect of Probiotic Supplementation on Endothelial Function II

CAD Inclusion Criteria
Age between 40-80 years old History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)
T2DM without CAD Inclusion Criteria

Age between 40-80 years old
History of known Diabetes Mellitus Type II as previously diagnosed by patient’s provider (ICD-9/10 code)

CAD Exclusion Criteria
Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
LV dysfunction as defined by an LV ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
Known history of cognitive impairment or inability to follow study procedures Patient with GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy.
Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.
Pregnancy Patients who is currently taking Vitamin K anatagonists such as coumadin, warfarin.
Those who are daily drinkers or use illicit drugs.
T2DM without CAD Exclusion Criteria
Hgb A1C > 9.5 % Coronary Artery Disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
LV dysfunction as defined by an LV ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
Known history of cognitive impairment or inability to follow study procedures Patient with GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy.
Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.
Pregnancy Patients who is currently taking Vitamin K anatagonists such as coumadin, warfarin.
Those who are daily drinkers or use illicit drugs.

Source: View full study details on ClinicalTrials.gov

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December 16, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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