N/A
Completed N=70
Lipid Biomarkers for Diabetic Heart Disease
Type II Diabetes Mellitus · Diabetes Complications
Source: ClinicalTrials.gov NCT01752842 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Change in Cardiac Diastolic Function as Measured by E' (cm/s) — -0.02; 0.55 cm/s — p=0.07
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.
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 |
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. Informational only — not medical advice.