N/A
N=70
Lipid Biomarkers for Diabetic Heart Disease
Type II Diabetes Mellitus · Diabetes Complications
Bottom Line
View on ClinicalTrials.gov: NCT01752842 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in Cardiac Diastolic Function as Measured by E' (cm/s) — -0.02; 0.55 cm/s — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fenofibrate (Drug); Placebo for fenofibrate (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cardiac Diastolic Function as Measured by E' (cm/s) |
-0.02; 0.55 | 0.07 |
| PRIMARY Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent |
0.025; 0.030 | 0.8128 |
| SECONDARY Change in C24:0/C16:0 Ceramide Ratio |
-1.6; -0.03 | 0.0034 sig |
Summary
This study will test whether lowering the delivery of excess fats to the heart in persons with type-2 diabetes mellitus improves heart muscle function. The investigators will also test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic heart disease.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
Exclusion Criteria
- body weight > 300 lb.
- HIV
- hypothyroid
- steroid medication, fenofibrate
- smoking
- BP > 140/90
- heart disease
- pregnant or lactating
- consumption of > 5 alcoholic drinks/wk
- creatinine > 1.5 mg/dL
- hematocrit < 28
Data sourced from ClinicalTrials.gov (NCT01752842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.