CompletedPhase 4

Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients

Egypt90 participantsStarted 2022-01-01

Plain-language summary

Metabolic associated fatty liver disease (MAFLD) is the most common and harmful chronic liver disease, and it is increasingly diagnosed in many developed and developing countries. Previous studies suggested a significant association between hyperuricemia and MAFLD and that hyperuricemia plays a causal role in the development of MAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism, and It thus can be considered as is a therapeutic target for MAFLD, so long-term urate-lowering therapy may play a role in amelioration of MAFLD by controlling uric acid levels. So, this study is conducted to assess the effect of controlling hyperuricemia using different xanthine oxidase inhibitors on amelioration of MAFLD.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 18-65. * Males and Females * Metabolic syndrome according to the NCEP ATP III definition \[13\]: present of three or more of the following five criteria are met: * Waist circumference over 40 inches (men) or 35 inches (women), Central obesity - defined as waist circumference ≥ 102 cm for Men and ≥ 88 cm for women * Blood pressure over 130/85 mmHg, * Basting triglyceride (TG) level over 150 mg/dl, * Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women), * Fasting blood sugar over 100 mg/dl. * Serum uric acid levels of \> 420μmol/L (\>7 mg/dL) in men and \>360 μmol/L (\>6 mg/dL) women. Exclusion Criteria: * Renal insufficiency defined by serum creatinine \> 2.0 mg/dl. * Patients with obvious abnormal liver function: serum transaminase (ALT, AST, one of them) exceed 2 times the upper limit of normal reference value. * Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases. * Complementation with diabetes, or fasting blood glucose \>7.8mmol/L, or HbA1c \>7.5%. * Severe hypertension, blood pressure ≥ 160/100 mmHg. * A history of allergy to febuxostat and allopurinol; in the acute active phase of gout. * Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female). * Complicated coronary heart disease. * Cardiac dysfunction (cardiac function grade 2 or above). * Patients with asthma and…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in hepatic steatosis .

Timeframe: 3 months

Trial details

NCT IDNCT05474560

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-28

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials