Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

University of Padova

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetic Retinopathy

Treatments: Drug: Placebo; Drug: Fenofibrate 145 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01927315

2871P

Details and patient eligibility

About

Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells".

Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication.

Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Full description

Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells".

Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. In addition to lowering triglyceride-rich lipoproteins, PPAR-alpha agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as reduction of inflammation. In a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication.

Preliminary data of ours on the effects of fenofibrate on cultured EPC show that this drug has the potential to improve EPC and, consequently, may benefit patients with retinopathy.

Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes
• Diabetic retinopathy
• Age 18-70
• Both sexes

Exclusion criteria

• Age <18 or >70 at enrollment
• Hereditary muscle disorders
• Uncontrolled hypothyroidism
• Elevated alcohol consumption
• Renal failure
• Hepatic failure
• Allergy to fenofibrate or excipients
• Acute / chronic pancreatitis
• Pregnancy and lactation.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

41 participants in 2 patient groups, including a placebo group

Fenofibrate

Experimental group

Description:

Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks

Treatment:

Drug: Fenofibrate 145 mg

Placebo

Placebo Comparator group

Description:

Placebo oral tablets daily for 12 weeks

Treatment:

Drug: Placebo