scholarly journals Effect of allopurinol on diabetic nephropathy; a double-blind clinical trial study

2020 ◽  
Vol 10 (1) ◽  
pp. e03-e03
Author(s):  
Saeed Mardani ◽  
Farzaneh Kadkhodaei-Elyaderani ◽  
Ali Momeni ◽  
Maryam Saeedi
Keyword(s):  
Clinical Trial ◽  
Diabetic Nephropathy ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Urinary Protein ◽  
Control Group ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Lymphocyte Ratio ◽  
Double Blind Clinical Trial

Introduction: Diabetic nephropathy (diabetic kidney disease) is the most common cause of renal failure. Objectives: Regarding the role of allopurinol in the improvement of diabetic kidney disease, this study aimed to investigate the ameliorative effect of allopurinol in diabetic nephropathy patients. Patients and Methods: This double-blind clinical trial study was performed on 60 patients with diabetic kidney disease referenced to nephrology clinic during 2019-2020. Patients were divided into case (treated with allopurinol 100 mg/d) and control (received placebo pill) groups. Three and six months of intervention, complete blood count (CBC), fasting blood sugar levels (FBS), serum blood urea nitrogen (BUN) levels, creatinine (Cr) and uric acid (UA) levels, 24 hours urinary protein, glomerular filtration rate (GFR), neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) were measured and compared between the two groups. Results: After six months, reduction of UA and 24 hours urinary protein were not significant in the control group (P > 0.05) but it was significant in the allopurinol group (P < 0.05). In the allopurinol group, NLR and PLR levels decreased significantly during the six months (P < 0.01) however there was no significant change in the control group (P > 0.05). Conclusion: Low dosage of allopurinol (100 mg/d) reduces UA, proteinuria, NLR and PLR in patients after six months. Therefore it can be used for diabetic nephropathy patients as a supplementary, inexpensive and safe treatment.

scholarly journals Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

2020 ◽  
Author(s):  
Rui Wu ◽  
Junping Wei ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Losartan Potassium ◽  
Blood Stasis Syndrome ◽  
Control Group ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a KLX treatment group (n=126) or a placebo control group (n=126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in the estimated glomerular filtration rate (eGFR; ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR >30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the traditional Chinese medicine (TCM) syndrome scale scores.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

scholarly journals Xiao Zheng San Jie Granules in the Treatment of Qi Deficiency and Blood Stasis Syndrome in Patients With Diabetic Kidney Disease Stage IV: Protocol for a Randomised, Double-blind, Placebo-controlled, Multi-centre Trial

2021 ◽  
Author(s):  
Sinan Ai ◽  
Yizhen Han ◽  
Yabin Gao ◽  
Yaoxian Wang ◽  
Jingwei Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Blood Stasis ◽  
Stage Iv ◽  
Blood Stasis Syndrome ◽  
Disease Stage ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Introduction Diabetic kidney disease (DKD) is a major microvascular complication of diabetes mellitus (DM) and the primary cause of end-stage renal disease. Routine medication might result in adverse effects which limit their usage. Laboratory studies have shown that Xiao Zheng San Jie (XZSJ) granules is effective in reducing the levels of urinary protein and blood creatinine in rats with DKD. Hence, we aim to conduct a clinical trial to determine the efficacy and safety of XZSJ granules among patients with DKD Stage IV, who present with the syndromes of qi deficiency and blood stasis. The purpose of this paper is to report the methodology of this trial.Methods and analysisThis is a randomised, double-blind, placebo-controlled, multi-centre clinical trial. A total of 72 patients with DKD Stage IV who have the syndromes of qi deficiency and blood stasis will be randomly assigned to either intervention or placebo group. In addition to routine medication, the intervention group will be given XZSJ formula (in granules) and the control group will be given placebo for 12-weeks. Data collected at baseline as well as weeks 4, 8 and 12 will be recorded in case report forms and subsequently entered into EpiData 3.1 electronic database. Adverse events will also be documented. Primary outcomes – estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and serum creatinine – will be assessed after 12 weeks. Ethics and disseminationThis trial has been approved by the Research Ethics Committee of Dongzhimen Hospital (DZMEC-KY-2018-60). Informed consent will be obtained from all participants. Results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.DiscussionThis trial might provide information on an effective method for the treatment of DKD, especially for patients who present with the syndromes of qi deficiency and blood stasis. We hope that this trial will serve as a reference for the conception of high-quality Traditional Chinese Medicine trials in the future, which incorporate syndrome diagnosis into the study design.Trial registration Chinese Clinical Trial Registry, ChiCTR1900021391. Registered 18 February 2018, http://www.chictr.org.cn/showproj.aspx?proj=36106.

scholarly journals Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

2020 ◽  
Author(s):  
Rui Wu ◽  
Junping Wei ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Primary Outcome ◽  
Microvascular Complications ◽  
Losartan Potassium ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n=126) a losartan potassium plus placebo group (n=126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR >30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be performed according to the data revealed by independent t tests, chi-squared tests, Fisher exact tests or Wilcoxon tests. All statistical tests will be two-sided, and significance will be considered for p-values <0.05.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

scholarly journals Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

2020 ◽  
Author(s):  
Rui Wu ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
Jun Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Primary Outcome ◽  
Wilcoxon Test ◽  
Losartan Potassium ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols and the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium alone in DKD treatment and to provide validated evidence for application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX group (n = 126) or a losartan potassium plus placebo group (n = 126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR > 30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be carried out according to the data features using an independent t test, chi-square test, Fisher exact test or Wilcoxon test. All statistical tests will be two-sided, and significance will be considered for a p value < 0.05.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus placebo for treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

scholarly journals Effects of Keluoxin capsule combined with losartan potassium on diabetic kidney disease: study protocol for a randomized double-blind placebo-controlled multicenter clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Rui Wu ◽  
Fan Wei ◽  
Lianlian Qu ◽  
Litao Bai ◽  
Jun Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Primary Outcome ◽  
Microvascular Complications ◽  
Losartan Potassium ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Background Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD. Methods We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n = 126) or a losartan potassium plus placebo group (n = 126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR > 30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be performed according to the data revealed by independent t tests, chi-squared tests, Fisher’s exact tests, or Wilcoxon’s tests. All statistical tests will be two-sided, and significance will be considered for p values < 0.05. Discussion This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD. Trial registration Chinese Clinical Trial Registry (www.chictr.org.cn) ChiCTR1900021113. Registered on January 29, 2019.

Diabetic kidney disease in thedb/dbmouse

2003 ◽  
Vol 284 (6) ◽  
pp. F1138-F1144 ◽  
Author(s):  
Kumar Sharma ◽  
Peter McCue ◽  
Stephen R. Dunn
Keyword(s):  
Diabetic Nephropathy ◽  
Kidney Disease ◽  
Mouse Model ◽  
Renal Disease ◽  
Mouse Models ◽  
Diabetic Kidney Disease ◽  
Diabetic Kidney ◽  
Matrix Expansion ◽  
Stage Renal Disease ◽  
End Stage

Diabetic nephropathy is increasing in incidence and is now the number one cause of end-stage renal disease in the industrialized world. To gain insight into the genetic susceptibility and pathophysiology of diabetic nephropathy, an appropriate mouse model of diabetic nephropathy would be critical. A large number of mouse models of diabetes have been identified and their kidney disease characterized to various degrees. Perhaps the best characterized and most intensively investigated model is the db/ db mouse. Because this model appears to exhibit the most consistent and robust increase in albuminuria and mesangial matrix expansion, it has been used as a model of progressive diabetic renal disease. In this review, we present the findings from various studies on the renal pathology of the db/ db mouse model of diabetes in the context of human diabetic nephropathy. Furthermore, we discuss shortfalls of assessing functional renal disease in mouse models of diabetic kidney disease.

scholarly journals Effects of Dapagliflozin on Circulating Markers of Phosphate Homeostasis

2018 ◽  
Vol 14 (1) ◽  
pp. 66-73 ◽  
Author(s):  
Maarten A. de Jong ◽  
Sergei I. Petrykiv ◽  
Gozewijn D. Laverman ◽  
Antonius E. van Herwaarden ◽  
Dick de Zeeuw ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Early Stage ◽  
Glycosylated Hemoglobin ◽  
Fibroblast Growth Factor 23 ◽  
Serum Phosphate ◽  
Phosphate Homeostasis ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Albumin Excretion

Background and objectivesThe sodium glucose cotransporter 2 (SGLT-2) inhibitor dapagliflozin is a novel drug for the treatment of diabetes mellitus. Recent studies suggest that SGLT-2 inhibitors affect phosphate homeostasis, but their effects on phosphate-regulating hormones in patients with diabetic kidney disease are still unclear.Design, setting, participants, & measurementsWe performed a post-hoc analysis of a double-blind, randomized, crossover trial in patients with type 2 diabetes with early-stage diabetic kidney disease on stable renin–angiotensin–aldosterone system blockade, with an albumin-to-creatinine ratio between 100 and 3500 mg/g, eGFR≥45 ml/min per 1.73 m2, and glycosylated hemoglobin≥7.2% and <11.4%. Patients were randomized to dapagliflozin 10 mg/d or placebo during consecutive 6-week study periods, separated by a 6-week wash-out. We investigated effects on circulating phosphate, calcium, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF23), 25-hydroxyvitamin D (25[OH]D), and 1,25-dihydroxyvitamin D (1,25[OH]2D) levels.ResultsThirty-one patients (age 62 years; 23% female) were analyzed. Compared with placebo, dapagliflozin increased serum phosphate by 9% (95% confidence interval, 4% to 15%; P=0.002), PTH increased by 16% (3% to 30%; P=0.01), FGF23 increased by 19% (0.3% to 42%; P=0.05), and serum 1,25(OH)2D decreased by −12% (−25% to 4%; P=0.12). Calcium and 25(OH)D were unaffected. We found no correlation between changes in markers of phosphate homeostasis and changes in eGFR or 24-hour albumin excretion during dapagliflozin treatment.ConclusionsDapagliflozin increases serum phosphate, plasma PTH, and FGF23. This effect was independent of concomitant changes in eGFR or 24-hour albumin excretion.

scholarly journals Urinary Markers of Glomerular Injury in Diabetic Nephropathy

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Abraham Cohen-Bucay ◽  
Gautham Viswanathan
Keyword(s):  
Renal Failure ◽  
Diabetic Nephropathy ◽  
Kidney Disease ◽  
Current Literature ◽  
Cardiovascular Events ◽  
Diabetic Kidney Disease ◽  
Glomerular Injury ◽  
Diabetic Kidney ◽  
Urinary Markers

Diabetic nephropathy, the leading cause of renal failure worldwide, affects approximately one-third of all people with diabetes. Microalbuminuria is considered the first sign and the best predictor of progression to renal failure and cardiovascular events. However, albuminuria has several limitations. Therefore, earlier, more sensitive and specific biomarkers with greater predictability are needed. The aim of this paper is to discuss the current literature on biomarkers of glomerular injury that have been implicated in diabetic kidney disease.

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