Status:
UNKNOWN
Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes
Lead Sponsor:
Zhongshan Hospital Xiamen University
Conditions:
Type 2 Diabetes
Diabetic Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 w...
Detailed Description
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 relation...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04127084
Start Date
October 15 2019
End Date
August 1 2021
Last Update
October 21 2019
Active Locations (1)
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1
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004