Arterial stiffness in patients with type 2 diabetes mellitus Circulatory System
Conditions
Interventions
Enrolled participants will be initiated either to dapagliflozin 10 mg or empagliflozin 10 or 25 mg once daily (oral route) for 24 weeks (6 months), according to the treating physician’s discretion, as
Sponsors
Aristotle University of Thessaloniki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 18-75 years old 3. Established diagnosis of type 2 diabetes mellitus (=12 months) 4. HbA1c values 6.5 – 10.0% 5. Stable antidiabetic and antihypertensive treatment over the last 6 months 6. Indication for the initiation or addition of new antidiabetic therapy with an SGLT-2 inhibitor according to the treating physician’s discretion 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. History of a serious adverse reaction to an SGLT-2 inhibitor 3. Renal dysfunction (estimated glomerular filtration rate <45 ml/min/1.73 m²) 4. Body mass index greater than 45 kg/m² 5. Uncontrolled hypertension despite optimal treatment (blood pressure =180/110 mmHg) 6. Liver dysfunction 7. Recent revascularization procedure or admission to hospital due to worsening of pre-existing heart failure (during the last 3 months) 8. Recent hospitalization due to diabetic ketoacidosis (during the last 3 months) 9. Alcohol or illicit drug intake 10. Pregnancy, possible pregnancy or breastfeeding 11. Participation of the patient in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambulatory pulse wave velocity (PWV) measured using the Mobilograph device at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ambulatory central pulse pressure measured using the Mobilograph device at baseline and after 6 months 2. Ambulatory augmentation index measured using the Mobilograph device at baseline and after 6 months 3. Rest parameters measured using the Mobilograph device at baseline and after 6 months | — |
Countries
Greece
Outcome results
None listed