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

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ClinicalTrials.gov Identifier: NCT04127084
Recruitment Status : Unknown
Verified October 2019 by Zhongshan Hospital Xiamen University.
Recruitment status was:  Recruiting
First Posted : October 15, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Diabetic Nephropathy Drug: SGLT2 Inhibition Phase 4

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 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 once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment. Endpoints: Primary outcome: evaluate the effects of SGLT2 inhibition treatment on on urinary albuminuria, kidney function and eGFR .

Secondary endpoints To assess the effect of SGLT2 inhibition on markers for podocyte damage , renal fibrosis, inflammation，oxidative stress and renin-angiotensin- aldosterone system。 Timeframe: Recruiting planned from October 2019, inclusion over the following 12 months. Last patient is expected to be completed October 2020. Data analysis completed December 2020, publication autumn 2021.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes: a Prospective Interventional Study
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: normal albuminuria
baseline urinary albumin creatinine ratio [UACR]< 30 mg/g
 Drug: SGLT2 Inhibition
Dapagliflozine 5-10 mg once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment
Other Name: Dapagliflozine,Empagliflozin,Canagliflozin
Experimental: moderately increased albuminuria
baseline UACR 30~300 mg/g
 Drug: SGLT2 Inhibition
Dapagliflozine 5-10 mg once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment
Other Name: Dapagliflozine,Empagliflozin,Canagliflozin
Experimental: severely increased albuminuria
baseline UACR>300mg/g
 Drug: SGLT2 Inhibition
Dapagliflozine 5-10 mg once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment
Other Name: Dapagliflozine,Empagliflozin,Canagliflozin
No Intervention: blank Comparator
normal participant


Outcome Measures
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Primary Outcome Measures :
  1. Change in urinary albuminuria [ Time Frame: Up to 12 weeks ]
    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)

  2. Change in eGFR [ Time Frame: Up to 12 weeks ]
    eGFR was calculated by modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease.

  3. change in nephrin [ Time Frame: Up to 12 weeks ]
    To assess effect of SGLT2 inhibition intervention on glomerular podocyte injury by detecting the expression of renal nephrin.

  4. change in TGF-β1 [ Time Frame: Up to 12 weeks ]
    To assess effect of SGLT2 inhibition intervention on glomerular and tubulointerstitial fibrosis by detecting the expression of TGF-β1

  5. change in IL-6 [ Time Frame: Up to 12 weeks ]
    To assess effect of SGLT2 inhibition intervention on inflammation biomarkers by detecting the levels of interleukin-6.

  6. change in TNFα [ Time Frame: Up to 12 weeks ]
    To evaluate the effects of SGLT2 inhibition treatment on inflammation, biomarkers by detecting the levels of tumor necrosis factor alpha.

  7. changes of AGEs [ Time Frame: Up to 12 weeks ]
    To evaluate the effects of SGLT2 inhibition treatment on oxidative stress index, the changes of AGEs.

  8. changes of 8-OH-dG [ Time Frame: Up to 12 weeks ]

    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



Secondary Outcome Measures :
  1. Change in uric acid [ Time Frame: Up to 12 weeks ]
    To evaluate the levels of serum uric acid before and after SGLT2 inhibition treatment.

  2. Change in aldosterone [ Time Frame: Up to 12 weeks ]
    To evaluate the levels of aldosterone before and after SGLT2 inhibition treatment.

  3. Change in rennin [ Time Frame: Up to 12 weeks ]
    To evaluate the levels of rennin before and after SGLT2 inhibition treatment

  4. Change in angiotensin [ Time Frame: Up to 12 weeks ]
    To evaluate the levels of angiotensin before and after SGLT2 inhibition treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127084


Contacts
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Contact: Xiao-min Chen, principal 8613860487599 chenxiaomin0517@sina.com
Contact: Yuan Tian, assistant 8618250865805 411954353@qq.com

Locations
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China, Fujian
Zhongshan Hospital Xiamen University Recruiting
Xiamen, Fujian, China, 361004
Contact: Yi-lin Zhao, principle    8613950085931      
Principal Investigator: Xiao-min Chen, principle         
Sub-Investigator: Yuan Tian, assistant         
Sponsors and Collaborators
Zhongshan Hospital Xiamen University
Investigators
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Study Director: Yi-lin Zhao, principal Zhongshan Hospital Xiamen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT04127084    
Other Study ID Numbers: 20191005
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zhongshan Hospital Xiamen University:
Type 2 diabetes
Diabetic Nephropathy
Albuminuria
SGLT2 inhibitor
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
 Proteinuria
Urination Disorders
Urological Manifestations
Empagliflozin
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs