Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4992
Source ID: NCT04127084
Associated Drug: Sglt2 Inhibition
Title: Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Diabetic Nephropathy
Interventions: DRUG: SGLT2 Inhibition
Outcome Measures: Primary: Change in urinary albuminuria, a clean-catch 24- hour urine sample and spot urine sample were collected to assess urinary albuminuria,which will be evaluated at week 0, and at end study week 12 (+/- 1 week), Up to 12 weeks|Change in eGFR, eGFR was calculated by modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease., Up to 12 weeks|change in nephrin, To assess effect of SGLT2 inhibition intervention on glomerular podocyte injury by detecting the expression of renal nephrin., Up to 12 weeks|change in TGF-β1, To assess effect of SGLT2 inhibition intervention on glomerular and tubulointerstitial fibrosis by detecting the expression of TGF-β1, Up to 12 weeks|change in IL-6, To assess effect of SGLT2 inhibition intervention on inflammation biomarkers by detecting the levels of interleukin-6., Up to 12 weeks|change in TNFα, To evaluate the effects of SGLT2 inhibition treatment on inflammation, biomarkers by detecting the levels of tumor necrosis factor alpha., Up to 12 weeks|changes of AGEs, To evaluate the effects of SGLT2 inhibition treatment on oxidative stress index, the changes of AGEs., Up to 12 weeks|changes of 8-OH-dG, To evaluate the effects of SGLT2 inhibition treatment on oxidative stress index by detecting the levels of 8-OH-dG. Urinary 8-OH-dG concentrations were assayed using a competitive enzyme-linked immunosorbent assay, Up to 12 weeks | Secondary: Change in uric acid, To evaluate the levels of serum uric acid before and after SGLT2 inhibition treatment., Up to 12 weeks|Change in aldosterone, To evaluate the levels of aldosterone before and after SGLT2 inhibition treatment., Up to 12 weeks|Change in rennin, To evaluate the levels of rennin before and after SGLT2 inhibition treatment, Up to 12 weeks|Change in angiotensin, To evaluate the levels of angiotensin before and after SGLT2 inhibition treatment, Up to 12 weeks
Sponsor/Collaborators: Sponsor: Zhongshan Hospital Xiamen University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-15
Completion Date: 2021-08
Results First Posted:
Last Update Posted: 2019-10-21
Locations: Zhongshan Hospital Xiamen University, Xiamen, Fujian, 361004, China
URL: https://clinicaltrials.gov/show/NCT04127084