Azienda Ospedaliero-Universitaria Sant Andre
Verified site
Rome, Italy
Not yet recruiting
Effect of febuxostat on insulin resistance in adults with cardiometabolic disease and mild chronic hyperuricemia: a randomized, double‑blind, placebo‑controlled trial
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The trial focuses on adults who have mild hyperuricemia together with a type of Cardiometabolic disease that affects how the body handles sugar and fat. The medication being tested is an oral tablet containing 80 mg of febuxostat, a drug that blocks the activity of xanthine oxidoreductase, an enzyme that can raise uric acid levels. A matching placebo tablet is also given to some participants so that the effects of the active drug can be compared.
The main aim is to find out whether taking febuxostat can lower insulin resistance, which is measured by a calculation called HOMA-IR. Participants are randomly assigned to receive either the active tablet or the placebo, and neither the participants nor the study staff know which one is given. Over the study period, participants take the assigned tablet once daily and attend regular visits for simple blood tests and basic health checks.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Age: You must be 18 years old or older.
- Hyperuricaemia: Your blood test must show a serum uric acid level higher than 5.6 mg/dL. Serum uric acid is a waste product measured in the blood.
- Uric acid‑to‑creatinine ratio above 5.35: This means the amount of uric acid compared to serum creatinine (a measure of kidney function) must be high, indicating that the uric acid elevation is not mainly due to kidney problems.
- Impaired glucose metabolism: Either your triglyceride‑to‑glucose index (a calculation using blood fats and sugar) must be greater than 5, or your fasting plasma glucose (blood sugar after not eating) must be between 100 and 125 mg/dL.
- Stable medication: Any medicines you are taking must have been unchanged for at least 4 weeks before joining the study, and you should not expect any major changes while you are in the trial.
- Informed consent: You must be willing and able to sign a written form agreeing to take part in the study before any study procedures begin.
Who cannot join the trial?
21 criteria
- Having diabetes (high blood sugar), whether already diagnosed or just discovered, or taking any medicine that lowers blood sugar.
- Needing more than two blood‑pressure medicines (antihypertensive agents) at the start of the study.
- Currently taking medicines that can change uric acid levels or affect study results, such as losartan, certain diuretics (thiazide‑type, thiazide‑like, or loop diuretics), SGLT2 inhibitors, or fenofibrate, and unable to switch them.
- Using any urate‑lowering medicine (a drug that lowers uric acid) other than the study drug.
- Taking azathioprine or mercaptopurine, which can dangerously interact with the study drug.
- Being allergic (hypersensitive) to febuxostat or to any inactive ingredient in the study medication or its placebo.
- Having rare genetic conditions that prevent processing certain sugars (galactose intolerance, lactase deficiency, or glucose‑galactose malabsorption) because the tablets may contain lactose.
- Having uncontrolled thyroid disease; only stable thyroid conditions with normal lab results while on steady medication are allowed.
- Having had a major heart or blood‑vessel problem such as a heart attack (myocardial infarction), stroke, or unstable chest pain (unstable angina).
- Having active cancer or receiving chemotherapy (cytotoxic anticancer treatment).
- Having Lesch‑Nyhan syndrome or any condition that causes very high uric acid production, which can lead to dangerous buildup of another substance called xanthine.
- Being an organ‑transplant recipient, because there is not enough safety information for this group.
- Having obvious gout or any other condition that already requires uric‑acid‑lowering therapy.
- Having very high “bad” cholesterol (LDL‑cholesterol) above 190 mg/dL.
- Having a body‑mass index (BMI) greater than 35 kg/m², which indicates severe obesity.
- Having reduced kidney function (eGFR) below 60 mL/min/1.73 m².
- Having severe liver disease (Child‑Pugh Class C) or active significant liver problems.
- Scoring higher than 6 on the Clinical Frailty Scale, indicating severe frailty.
- Having a life expectancy of less than one year.
- Being pregnant or breastfeeding.
- For women who could become pregnant: having a positive pregnancy test or not being willing or able to use a highly effective birth‑control method during the study period.
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Verified sites
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ASST Grande Ospedale Metropolitano Niguarda
Verified siteMilan, ItalyAzienda Ospedaliera Universitaria Federico II Di Napoli
Verified siteNaples, Italy
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Investigated drugs
Febuxostat is a tablet taken by mouth that works by blocking an enzyme called xanthine oxidoreductase. This enzyme helps produce uric acid, so when it is blocked, the amount of uric acid in the blood goes down. In this study, the drug is being tested to see if lowering uric acid can also improve how the body handles insulin, which may help reduce insulin resistance in people who have slightly high uric acid levels and problems with glucose metabolism.
What is already known about the treatment
Febuxostat - Febuxostat is taken as an 80 mg oral tablet once daily. It is an approved drug used to lower uric acid in people with gout and chronic hyperuricemia and is well described in medical literature. The medicine works by blocking the enzyme xanthine oxidase, which stops the body from making excess uric acid. It belongs to the class of xanthine oxidase inhibitors, also called urate‑lowering agents.
Investigated diseases
Cardiometabolic disease
a condition that combines problems of the heart and metabolism, such as high blood pressure, abnormal blood fats, and reduced ability to use insulin. It usually develops slowly as lifestyle and genetic factors cause the body’s energy handling to become less efficient. Over time the heart and blood vessels may experience increasing strain, while blood sugar control can become poorer. The disease often progresses from mild changes in blood tests to more noticeable signs like weight gain and fatigue.
Mild chronic hyperuricemia
a long‑lasting, slightly elevated level of uric acid in the blood. It can result from the body making too much uric acid or not removing it well through the kidneys. The level typically rises gradually and can stay relatively stable for many years. As the concentration increases, tiny crystals may begin to form in joints or tissues, although early stages may cause no obvious symptoms.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526401-15-00Estimated enrolment248 patients
sourced from the EU Clinical Trials Register and site verification
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