Type 2 Diabetes Clinical Trial
Official title:
Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes: a Prospective Interventional Study
Diabetic kidney disease has become the leading cause for ESRD worldwide.Albuminuria is a major risk factor for progression of diabetic nephropathy. SGLT2 inhibitors are the first antiglycaemic drugs with direct renoprotection, which are thought to protect the kidneys by lowering albuminuria, stimulating urinary glucose excretion ,reducing systemic blood pressure, while simultaneously improving multiple other risk factors in a glucose-independent manner. However, the precise mechanisms behind the renal beneficial effect of SGLT2 inhibitors are not entirely elucidated, although ongoing outcome trials will confirm these findings. This study is to assess the impact of three months of treatment with SGLT2 Inhibitions on different levels of albuminuria in patients with type 2 diabetes and to evaluate the effects of SGLT2 inhibition treatment on markers for podocyte damage , renal fibrosis, inflammation，oxidative stress and renin-angiotensin- aldosterone system.
Objective: The primary objective is to assess the impact of three months of treatment with
SGLT2 Inhibition on Different levels of Albuminuria in Patients With type 2 diabetes and to
seek the relationship of this influences to relevant risk markers in the pathology of
diabetic renal disease.
Design: prospective ，intervention， case-controlled , single center study. Treatment period:
12 weeks. Patient population: 60 patients with type 2 diabetes recruited from Zhongshan
Hospital Xiamen University in accordance with the study in- and exclusion criteria.
Intervention: Dapagliflozine 10 mg once daily tablet treatment or Empagliflozin10 mg once
daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment. Endpoints:
Primary outcome: evaluate the effects of SGLT2 inhibition treatment on on urinary
albuminuria, kidney function and eGFR .
Secondary endpoints To assess the effect of SGLT2 inhibition on markers for podocyte damage ,
renal fibrosis, inflammation，oxidative stress and renin-angiotensin- aldosterone system。
Timeframe: Recruiting planned from October 2019, inclusion over the following 12 months. Last
patient is expected to be completed October 2020. Data analysis completed December 2020,
publication autumn 2021.
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