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Evaluation of fenofibrate treatment on beta cell function in children and adolescents newly diagnosed with type 1 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with newly diagnosed Type 1 Diabetes, specifically in children and adolescents. The research evaluates how fenofibrate, a medication that affects fat metabolism, might help preserve the function of special cells in the pancreas called beta cells. These cells are responsible for producing insulin, which is essential for controlling blood sugar levels.

The study compares two groups of participants - one receiving fenofibrate tablets and another receiving a placebo. The medication or placebo will be taken orally once daily at a dose of 160 mg for up to 52 weeks. Neither the participants nor their doctors will know which treatment they are receiving during the study period.

The main goal is to determine if fenofibrate can help maintain the remaining function of insulin-producing cells in the pancreas of young patients with newly diagnosed Type 1 Diabetes. Throughout the study, researchers will monitor various aspects of diabetes control, including blood sugar levels, insulin requirements, and markers of inflammation in the body. The study will also evaluate how safe and well-tolerated the medication is in young patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    You will undergo initial evaluation to confirm eligibility for the study

    If you are female, a pregnancy test will be performed

    You will receive detailed information about the treatment plan and required tests

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either fenofibrate or placebo

    The medication will be in the form of film-coated tablets

    If assigned to the treatment group, you will receive fenofibrate 160 mg taken once daily by mouth

  3. Step 3

    Regular monitoring

    Your pancreatic function will be monitored through C-peptide tests (a measure of insulin production)

    Regular blood tests will check your blood sugar control (HbA1c)

    Your daily insulin requirements will be tracked

    Blood tests will monitor inflammation markers

  4. Step 4

    Ongoing assessments

    Your blood sugar levels and variations will be regularly monitored

    The medical team will track the time your blood sugar stays within normal range

    The safety and tolerance of the medication will be evaluated throughout the study

  5. Step 5

    Study duration

    The study continues until December 31, 2024

    You must use effective birth control methods throughout the study period if applicable

    Regular follow-up visits will be scheduled to monitor your progress

Who can join the trial?

11 criteria

  • Participants must be between 10 and 17 years old
  • Both the participant and their legal representative must be able to understand and sign the informed consent forms:
    • Parents/guardians must sign the consent form for minors
    • Children aged 10-15 must sign a children's assent form
    • Adolescents aged 16-17 must sign an adolescent assent form
    • Must have been diagnosed with type 1 diabetes within 8 weeks before study start according to Polish Diabetes Association criteria
    • For female participants:
      • Must not be pregnant or breastfeeding
      • If menstruating, must have a negative pregnancy test at first visit
      • Must either practice abstinence or use effective birth control throughout the study
      • Acceptable birth control methods include:
        • Intrauterine device in place for at least 3 months
        • Condom or diaphragm with spermicide (must be used at least 14 days before first visit)
        • Hormonal contraception (must be stable for at least 2 months before first visit)

Who cannot join the trial?

15 criteria

  • Age below 10 years or above 17 years
  • Presence of any other type of diabetes besides type 1 diabetes
  • Known allergies to fenofibrate or similar medications
  • Severe kidney problems (as fenofibrate is processed by the kidneys)
  • Liver disease or abnormal liver function tests
  • Diagnosis of type 1 diabetes more than 6 weeks ago
  • Currently taking medications that could interact with fenofibrate
  • History of pancreatitis (inflammation of the pancreas)
  • Participation in other clinical trials within the last 30 days
  • Presence of any serious medical conditions that could affect study results
  • Inability to swallow tablets
  • Pregnancy or breastfeeding
  • History of non-compliance with medical treatments
  • Diabetic ketoacidosis (a serious complication of diabetes) at the time of screening
  • Mental conditions that could interfere with following study procedures
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Investigated drugs

Fenofibrate is a medication that helps control blood fat levels. In this trial, it is being studied to see if it can help preserve the function of insulin-producing cells (called beta cells) in the pancreas of children who have recently been diagnosed with type 1 diabetes. This medication typically helps lower triglycerides and cholesterol levels, but researchers are investigating if it might also help protect the cells that produce insulin in people with diabetes.

What is already known about the treatment

Fenofibrate - A lipid-lowering medication administered orally in tablet form, typically taken once daily with meals. This medication belongs to the fibrate class of drugs and works by reducing the production of triglycerides in the liver while increasing the production of good cholesterol (HDL). Currently, it is being studied in clinical trials for potential benefits in preserving pancreatic beta cell function in children with newly diagnosed type 1 diabetes, representing a novel therapeutic approach beyond its traditional use in managing blood lipid levels. The mechanism of action involves activating peroxisome proliferator-activated receptor alpha (PPAR-alpha), which regulates genes involved in lipid metabolism and may have additional protective effects on pancreatic cells.

Investigated diseases

Type 1 Diabetes - A chronic condition where the immune system attacks and destroys insulin-producing beta cells in the pancreas. This results in the body producing little or no insulin, which is essential for regulating blood sugar levels. The condition typically develops during childhood or adolescence, causing increased thirst, frequent urination, hunger, fatigue, and weight loss. Over time, the pancreas produces less and less insulin as more beta cells are destroyed. The body's inability to properly process glucose leads to higher than normal blood sugar levels. Note: I've provided only the disease mentioned in the source data (Type 1 Diabetes), following the specified format and guidelines. The description focuses on what the disease is and how it progresses, avoiding treatment information and maintaining accessibility for non-medical readers.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-517483-34-00Protocol codePRIFEN-01Estimated enrolment98 patientsSponsorMedical University Of Warsaw

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