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| Name | Class |
|---|---|
| Azienda Ospedaliera di Padova | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate | Experimental | Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo oral tablets daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate 145 mg | Drug | Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial progenitor cells | Change in endothelial progenitor cell (EPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks. | 12 weeks |
| Circulating progenitor cells | Change in circulating progenitor cell (CPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | Change in Triglycerideslevels in fenofibrate-treated vs placebo-treated patients over 12 weeks. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gian Paolo Fadini, MD PhD | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Padova, Diabetes Outpatient Clinic | Padova | 35100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34368894 | Derived | Bonora BM, Albiero M, Morieri ML, Cappellari R, Amendolagine FI, Mazzucato M, Zambon A, Iori E, Avogaro A, Fadini GP. Fenofibrate increases circulating haematopoietic stem cells in people with diabetic retinopathy: a randomised, placebo-controlled trial. Diabetologia. 2021 Oct;64(10):2334-2344. doi: 10.1007/s00125-021-05532-1. Epub 2021 Aug 9. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Single blind
| Placebo | Drug | Oral Placebo tablets once daily |
|
|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |