Diabetes Mellitus, Type 2
Conditions
Keywords
Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine
Brief summary
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.
Interventions
DRUGEmpagliflozin
DRUGPlacebo
Sponsors
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Henrik Enghusen Poulsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes * HbA1c: 6.5-9.0% * Capable of understanding oral- and written information * Caucasian
Exclusion criteria
* Estimated glomerular filtration rate (eGFR) \< 60 mL/hour/1.73 m2 * Currently receiving insulin treatment * Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months * Genital infection within 14 days * Plasma alanine aminotransferase ≥3 times upper normal limit * Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months * Hyperglycaemic symptoms * Psychiatric disorder * Intolerance to empagliflozin or other agents relevant to study * Non-compliant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h) | Change from baseline after fourteen days of intervention |
| Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h) | Change from baseline after fourteen days of intervention |
Secondary
| Measure | Time frame |
|---|---|
| Plasma levels of malondialdehyde | Change from baseline after fourteen days of intervention |
| Plasma levels of iron, ferritin, transferrin and transferrin saturation | Measured at baseline and after intervention |
Countries
Denmark
Outcome results
None listed