None listed
Conditions
Brief summary
Gout is the result of high levels of uric acid in the blood depositing in the joints. It can also deposit in the kidneys and is associated with kidney disease, cardiovascular disease and death. The treatment for gout is tablets that lower uric acid in the blood stream, but most people with gout aren’t prescribed uric acid lowering therapies, or simply don’t take their medications. People with diabetes have are more at risk of developing gout than people without diabetes, due to high levels of uric acid in the blood. This study aims to identify the extent to which current diabetes medications may lower uric acid; with the hope of avoiding the need to add additional therapies to treat gout in people who already take many medicines. This is likely to increase adherence to gout therapy in people with diabetes, improving outcomes and decreasing the long term complications of gout including joint pain and death form cardiovascular disease.
Interventions
Each participant will be randomised by computer-generated code to receive empagliflozin 25 mg daily orally for one week, fenofibrate 145 mg daily orally for one week, or the combination of empagliflozin 25 mg and fenofibrate 145 mg daily for one week, with each active treatment period separated by a one-week washout period. Tablet checks will be done at each of each active treatment period.
Sponsors
Timothy Davis
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Type 2 diabetes diagnosed at least 3 months previously and treated with stable oral blood glucose lowering therapies • Age between 18 and 70 years apart from women of child-bearing age who will be excluded. • Body mass index between 20 and 40 kg/m² • Glycated haemoglobin >6.5% and <9.0% • Hyperuricaemia (serum uric acid above the upper limit of the laboratory reference range i.e. greater than to equal to 0.42 mmol/L) • No current therapy with either an SGLT2i or a fibrate, or allopurinol or febuxostat • No history of intolerance or adverse effects with past use of an SGLT2i or a fibrate • No contraindications to SGLT2i or fibrate use including renal impairment (eGFR <45 mL/min), past history of recurrent genitourinary infections and/or symptomatic postural hypotension • Stable doses of any medications (such as aspirin and thiazide diuretics) known to influence serum uric acid concentrations • Stable alcohol intake of <3 standard drinks/day • No recent history of smoking • No significant co-morbidity such as cancer or mental health issues that would affect the ability to follow a normal lifestyle and take regular medications including allocated • Ability to provide written informed consent and to attend all scheduled study assessments
Exclusion criteria
• Type 1 or other non-Type 2 forms of diabetes • Diagnosed within the last 3 months • Recent changes in oral blood glucose lowering therapies • Age lower than 18 years and greater than 70 years • Women of child-bearing age • Body mass index below 20 and greater than40 kg/m² • Glycated haemoglobin <6.5% and >9.0% • Normal serum uric acid (below the upper limit of the laboratory reference range or <0.42 mmol/L) • Current therapy with either an SGLT2i or a fibrate, or allopurinol or febuxostat • A history of intolerance or adverse effects with past use of an SGLT2i or a fibrate • Contraindications to SGLT2i or fibrate use including renal impairment (eGFR <45 mL/min), past history of recurrent genitourinary infections and/or symptomatic postural hypotension • Unstable doses of any medications (such as aspirin and thiazide diuretics) known to influence serum uric acid concentrations • Alcohol intake of >3 standard drinks/day • Recent smoking • Significant co-morbidity such as cancer or mental health issues that would affect the ability to follow a normal lifestyle and take regular medications including allocated • Inability to provide written informed consent and to attend all scheduled study assessments
Outcome results
None listed