The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br>One tablet 25 mg empagliflozin every morning for 14 days | Drug: Empagliflozin<br> <br> |
| Placebo Comparator: Placebo<br>One tablet placebo every morning for 14 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine