Status:
COMPLETED
Effect of Probiotic Supplementation on Endothelial Function II
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Cardiovascular Disease
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Researchers at MCW have discovered a new pathway that links the type of bacteria present in the intestines to the severity of heart attacks. This discovery of a relationship between intestinal bacteri...
Detailed Description
Recently, a direct link between intestinal microbiota, dietary phosphatidylcholine, and promotion of cardiovascular disease has been elegantly demonstrated. In this study, broad spectrum antibiotics w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2025
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03267758
Start Date
May 15 2018
End Date
October 16 2025
Last Update
November 26 2025
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226