| Trial ID: | L5262 |
| Source ID: | NCT01752842
|
| Associated Drug: |
Fenofibrate
|
| Title: |
Lipid Biomarkers for Diabetic Heart Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01752842/results
|
| Conditions: |
Type II Diabetes Mellitus|Diabetes Complications
|
| Interventions: |
DRUG: Fenofibrate|DRUG: Placebo for fenofibrate
|
| Outcome Measures: |
Primary: Change in Cardiac Diastolic Function as Measured by E' (cm/s), Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline., Baseline and 12 weeks|Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent, Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline., Baseline and 12 weeks | Secondary: Change in C24:0/C16:0 Ceramide Ratio, Mass spectrometry-based quantification of the ratio of C24:0 ceramide to C16:0 ceramide in plasma., Baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Washington University School of Medicine | Collaborators: National Institutes of Health (NIH)|National Heart, Lung, and Blood Institute (NHLBI)|Leducq Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03
|
| Completion Date: |
2018-02-23
|
| Results First Posted: |
2019-02-26
|
| Last Update Posted: |
2019-03-15
|
| Locations: |
Washington University School of Medicine, Saint Louis, Missouri, 63110, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01752842
|
