Fenofibrate in Type 2 Diabetes

Diabetes Mellitus, Type II Clinical Trial

Official title:

Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829514
• Other study ID #: Pro00079289
• Status: Completed
• Phase: Phase 4
• Start date: February 4, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: October 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Fenofibrate
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Six weeks, from baseline visit to study completion visit