UnknownPhase 4

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

China70 participantsStarted 2019-10-15

Plain-language 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 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in urinary albuminuria

Timeframe: Up to 12 weeks

Change in eGFR

Timeframe: Up to 12 weeks

change in nephrin

Timeframe: Up to 12 weeks

change in TGF-β1

Timeframe: Up to 12 weeks

change in IL-6

Timeframe: Up to 12 weeks

change in TNFα

Timeframe: Up to 12 weeks

changes of AGEs

Timeframe: Up to 12 weeks

changes of 8-OH-dG

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT04127084

SponsorZhongshan Hospital Xiamen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10

Contact for this trial

Xiao-min Chen, principal

8613860487599 chenxiaomin0517@sina.com

View on ClinicalTrials.gov More Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in urinary albuminuria

Timeframe: Up to 12 weeks

Change in eGFR

Timeframe: Up to 12 weeks

change in nephrin

Timeframe: Up to 12 weeks

change in TGF-β1

Timeframe: Up to 12 weeks

change in IL-6

Timeframe: Up to 12 weeks

change in TNFα

Timeframe: Up to 12 weeks

changes of AGEs

Timeframe: Up to 12 weeks

changes of 8-OH-dG

Timeframe: Up to 12 weeks