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Fenofibrate in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03829514
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Timothy Lyons, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Fenofibrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Experimental: Fenofibrate
Single arm. Participants will take study medication
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.
Other Names:
  • Trilipix
  • Triglide
  • Antara




Primary Outcome Measures :
  1. change in levels of individual plasma proteins, measured as ion current, in proteomic analysis via liquid chromatography-mass spectrometry [ Time Frame: Baseline through six weeks ]
    Plasma proteomics enables the study of complex disease processes. Combined with bioinformatics, proteomics is a powerful and unbiased approach that can identify pathways for the multi-organ benefits of fenofibrate, defining new target



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829514


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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Responsible Party: Timothy Lyons, Professor and Chief, Division of Endocrinology, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03829514    
Other Study ID Numbers: Pro00079289
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents