To evaluate the effect of dapagliflozin treatment on urinary proteomic patterns in patients with Type 2 diabetes, microalbuminuria, and eGFR equal to or above 45ml/min/1.73m2
Evaluation of the intervention on other measures:
- 24-hour blood pressure
- Albuminuria (UAER)
- Oxidative stress
- Tubular function
- Endothelial dysfunction
- Kidney Function (GFR)
- Vasoactive hormones
Global longitudinal strain
Design and method
Randomised, double blinded, placebo controlled, crossover (2x12 weeks), single centre study on dapagliflozin vs. placebo.
Expected ending and outcome
Dapagliflozin treatment will have a beneficial impact on renal urinary peptide patterns.
Dapagliflozin treatment will have a beneficial impact on albuminuria, 24h blood pressure, the microcirculation and markers of inflammation, oxidative stress, tubular function, endothelial dysfunction, and global longitudinal strain. Due to a loss of sodium a change in vasoactive hormones will be seen. The influence of treatment on kidney function will be precisely assessed by direct GFR measurement.
Astra Zeneca supports the study by a research grant
The following partners will carry out analysis of blood and/ or urine:
- Prof. Dr. Harald Mischak, Mosaiques Diagnostics, Hannover (Tyskland)
- Coen D.A. Stehouwer, MD, PhD, FESC, Maastricht University Medical Centre, Maastricht (Holland)
- Erling Bjerregaard Pedersen, Professor, Chief Physician dr. med., Holstebro Hospital
- Niklas Rye Jørgensen, Klinisk professor, PhD, dr.med., Klinisk Biokemisk Afdeling, Rigshospitalet, GlostrupGlostrup Hospital
- Jens Faber, Professor, MD, DMSci, Department of Medicine O, Endocrine Unit, Herlev University Hospital