Back to resultsFenofibrate in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type II
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type II
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)
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fenofibrate
Arm Description
Single arm. Participants will take study medication
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03829514
First Posted
January 25, 2019
Last Updated
October 5, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03829514
Brief Title
Fenofibrate in Type 2 Diabetes
Official Title
Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenofibrate
Arm Type
Experimental
Arm Description
Single arm. Participants will take study medication
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Trilipix, Triglide, Antara
Intervention Description
40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Six weeks, from baseline visit to study completion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Fenofibrate in Type 2 Diabetes
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