Fenofibrate in Type 2 Diabetes

NCT ID: NCT03829514

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2020-03-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fenofibrate

Single arm. Participants will take study medication

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Trilipix; Triglide; Antara

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Timothy Lyons

Professor and Chief, Division of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00079289

Identifier Type: -

Identifier Source: org_study_id