Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes

Launched by ZHONGSHAN HOSPITAL XIAMEN UNIVERSITY · Oct 11, 2019

Keywords

ClinConnect Summary

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 onc...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients between 18 -80 years of age with a diagnosis of type 2 diabetes (WHO criteria).
• • 2. HbA1c of 7-11 %
• • 3. eGFR equal to or above 45 ml/min/1.73 m2
• • 4. The Trial included 20 normal albuminuria (Urinary albumin creatinine ratio \[UACR\]\< 30 mg/g, with 20 moderately increased albuminuria UACR 30\~300 mg/g, and 20 severely increased albuminuria UACR\>30 0mg/g (in ≥2 out 3 morning spot urine collections prior to enrolment ).at baseline.
• • 5. Patients who agree to receive treatment with SGLT2 inhibitors.
• • 6. Patients must be on current stable hemodynamic profile , without dehydration.
• • 7. Patients must be on current stable antiglycaemic treatment with oral drugs (OAD) or insulin 4 weeks before start of study drug and throughout study duration.
• • 8. Patients must be on stable antihypertensive treatment (not include renin-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration.
• Exclusion Criteria:
• • 1. type 1 diabetes
• • 2. Patients who suffer from recent acute complications including diabetic ketoacidosis and hyperglycaemic hyperosmolar coma, which may be at risk for dehydration.
• • 3. Patients with hypertension who are not on stable antihypertensive treatment
• • 4. urinary tract or reproductive tract acute infection
• • 5. impaired liver function, defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
• • 6. History of unstable or rapidly progressing renal disease
• • 7. impaired renal function ,eGFR: \<45 mL/min (calculated by MDRD formula)
• • 8. Ongoing cancer treatment
• 9. Recent Cardiovascular Events in a patient:
• • 9.1. Acute Coronary Syndrome (ACS) within 2 months prior to enrolment 9.2.Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment9. 3. Acute Stroke or TIA within two months prior to enrolment 9. 4. Less than two months post coronary artery revascularization
• • 10. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure..
• • 11. Pregnant or breastfeeding patients
• • 12. smoker.