I67
Conditions
Interventions
Group 1: Substudy 1
High-intensity exercise
Substudy 2
High-intensity exercise after a single dose of empagliflozin (10 mg, oral)
Sponsors
Universitätsklinik Magdeburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age • Young subjects: 18–30 years • Older subjects: = 65 years • 3T MRI-compatible (e.g., no tinnitus, no tattoos, no magnetic implants) • No manifest depression (BDI 26) • Current laboratory results showing normal kidney function (defined as a normal GFR of >60 ml/min/1.73 m²) Fee
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding Severe cardiac disease (e.g., acute coronary syndrome, symptomatic severe aortic stenosis, decompensated heart failure, acute pulmonary embolism, acute inflammatory heart disease, acute aortic dissection, hypertensive crisis at rest >180/100 mmHg, pacemaker) Orthopedic conditions (e.g., bone fractures within the last 6 months, symptomatic herniated disc) Muscular diseases (e.g., myositis or tendovaginitis) History of neurological or psychiatric conditions (including seizure disorders, stroke, severe traumatic brain injury, Parkinson's disease, motor neuron diseases, neuromuscular diseases, storage diseases/mitochondrial disorders, multiple sclerosis, depression, schizophrenia, bipolar disorder) Recent laboratory tests showing impaired kidney function (defined as a reduced GFR of <60 ml/min/1.73 m²) • Known allergies to gadolinium-based contrast agents or other contrast agent formulations • Known intolerance to empagliflozin • Empagliflozin or other SGLT-2 inhibitors currently on the patient's medication list
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| microvascular function according to the STRIVE criteria in MRI after intervention or 24-hour follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| -Biomarkers (inflammation, extracellular vesicles, growth factors) -Cardiovascular parameters (TTE, PWV, retinal fundus) -Exercise-induced hypertension -Questionnaires (physical activity, stress, sleep) | — |
Countries
Germany
Contacts
Public ContactPatrick Müller
Universitätsklinik Magdeburg
Outcome results
None listed