Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes
Type 2 Diabetes, Diabetic Nephropathy
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Diabetic Nephropathy, Albuminuria, SGLT2 inhibitor
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between 18 -80 years of age with a diagnosis of type 2 diabetes (WHO criteria).
- HbA1c of 7-11 %
- eGFR equal to or above 45 ml/min/1.73 m2
- 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.
- Patients who agree to receive treatment with SGLT2 inhibitors.
- Patients must be on current stable hemodynamic profile , without dehydration.
- 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.
- 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:
- type 1 diabetes
- Patients who suffer from recent acute complications including diabetic ketoacidosis and hyperglycaemic hyperosmolar coma, which may be at risk for dehydration.
- Patients with hypertension who are not on stable antihypertensive treatment
- urinary tract or reproductive tract acute infection
- impaired liver function, defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- History of unstable or rapidly progressing renal disease
- impaired renal function ,eGFR: <45 mL/min (calculated by MDRD formula)
- Ongoing cancer treatment
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
- Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure..
- Pregnant or breastfeeding patients
- smoker.
Sites / Locations
- Zhongshan Hospital Xiamen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
normal albuminuria
moderately increased albuminuria
severely increased albuminuria
blank Comparator
baseline urinary albumin creatinine ratio [UACR]< 30 mg/g
baseline UACR 30~300 mg/g
baseline UACR>300mg/g
normal participant