Probiotic effects on heart health and diabetes
Effect of Probiotic Supplementation on Endothelial Function II
This study is testing if taking probiotics can improve heart health and diabetes symptoms in people with cardiovascular disease and type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03267758 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of probiotic supplementation on endothelial function in patients with cardiovascular disease and type 2 diabetes. Researchers aim to explore the relationship between intestinal bacteria and heart attack severity, leveraging findings that suggest altered gut microbiota may influence cardiovascular health. Participants will receive either a probiotic or placebo, and the study will measure inflammatory markers and endothelial function to assess the potential benefits of probiotics in improving heart health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-80 with a history of coronary artery disease or type 2 diabetes without coronary artery disease.
Not a fit: Patients with unstable angina, recent myocardial infarction, or significant heart dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for preventing heart attacks in patients with cardiovascular disease and diabetes.
How similar studies have performed: Previous studies have shown promising results linking gut microbiota to cardiovascular health, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 1. Age between 40-80 years old 2. 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.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michael Widlansky, MD — Medical College of Wisconsin
- Study coordinator: Michael Widlansky, MD
- Email: mwidlans@mcw.edu
- Phone: 414-955-6759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.