Phase 4
Completed N=10
Fenofibrate in Type 2 Diabetes
Diabetes Mellitus, Type II
Source: ClinicalTrials.gov NCT03829514 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry — 0 Proteins — p=0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in diabetic retinopathy offers an important translational research opportunity. The investigator's global proteomic study will provide new clues as to how fenofibrate protects vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry |
— | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes of at least one year's duration; stable glycemic control (no more than 1.0% change in HbA1c in the previous six months, but no limit on HbA1c)
- Triglycerides >150 mg/dL (in the previous six months)
Exclusion Criteria
- Previous use of Fenofibrate or other fibrates
- Pregnancy
- Active malignancy
- Recent cardiac event or congestive heart failure
- Active liver disease
- Significant renal impairment (serum creatinine > 2mg/dl)
Data sourced from ClinicalTrials.gov (NCT03829514). 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.