Fenofibrate in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type II
• Interventions: Drug: Fenofibrate

• Registration Number: NCT03829514
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-02-01
• Study Start: 2019-02-04
• Study First Posted: 2019-02-04
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Disposition First Submitted: 2021-02-17
• Results First Submitted: 2021-09-08
• Results First Submitted QC: 2022-01-11
• Disposition First Submitted QC: 2022-01-11
• Results First Posted: 2022-02-08
• Disposition First Posted: 2022-02-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fenofibrate	Fenofibrate	Single arm. Participants will take study medication

Primary Outcome Measures

Name	Time	Method
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	Six weeks, from baseline visit to study completion visit	Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States