| Trial ID: | L3322 |
| Source ID: | NCT00865124
|
| Associated Drug: |
Spironolactone
|
| Title: |
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00865124/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Vascular Disease
|
| Interventions: |
DRUG: Spironolactone|DRUG: Hydrochlorothiazide + potassium|OTHER: Placebo
|
| Outcome Measures: |
Primary: Change in Coronary Flow Reserve From Baseline to 6 Months, Coronary flow reserve (CFR), or myocardial perfusion reserve, was assessed via cardiac positron emission tomography (PET). CFR is the ratio of adenosine-stimulated blood flow through myocardium to resting blood flow through myocardium. An improvement in coronary flow reserve is beneficial., Baseline and six months | Secondary: Change in Mitral Annulus Velocities on Tissue Doppler (Delta E/e' Ratio), a Measure of Diastolic Function, Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment., Baseline and six months|Mitral Annulus Velocities on Tissue Doppler (Delta E/e' Ratio), a Measure of Diastolic Function (With Angiotensin II), Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment; and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II., Baseline and six months|Change in Renal Plasma Flow, Renal vasculature was assessed by examining renal plasma flow, or para-aminohippurate (PAH) clearance, basally and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II., Baseline and six months
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital | Collaborators: National Institutes of Health (NIH)|National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
69
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-09
|
| Completion Date: |
2014-05
|
| Results First Posted: |
2017-06-14
|
| Last Update Posted: |
2017-06-14
|
| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00865124
|
