Fenofibrate in Type 2 Diabetes

NCT03829514 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00079289
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fenofibrate

EXPERIMENTAL

Single arm. Participants will take study medication

Drug: Fenofibrate

Interventions

Fenofibrate DRUG

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.

Also known as: Trilipix, Triglide, Antara

Fenofibrate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Misti Leyva
• Organization: Medical University of South Carolina

leyva@musc.edu

endo office

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Endocrinology

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 4, 2019
• Study Start: February 4, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: October 24, 2023
• Results First Posted: February 8, 2022

Record last verified: 2023-10

Locations

US (1)