Effects of Tangshen Formula on urinary and plasma liver-type fatty acid binding protein levels in patients with type 2 diabetic kidney disease: post-hoc findings from a multi-center, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Tangshen Formula in patients with type 2 diabetic kidney disease

Abstract Abstract Background: Diabetic kidney disease (DKD) is the main cause of end stage kidney disease (ESKD) and It has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing micro-and macro-albuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD. Methods/design: This trial is a thirteen-center, randomized, double-blind, placebo-controlled study. 623 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus Losartan) and a control group (placebo plus Losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in Urine microalbumin creatinine ratio （ ACR ） from baseline to week 24. The secondary outcome will be the change in the rate of progression into the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, doubling rate of baseline creatinine value and glomerular filtration rate (GFR) between the two groups. Safety in medication will also be evaluated. Discussion: We hypothesize that type 2 diabetic patients in early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration: ClinicalTrials.gov (NCT03009864) Keywords: Diabetes Kidney Disease, Traditional Chinese medicine, Treatment, Randomized controlled trial

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Efficacy and Safety of Tangshen Formula on Patients with Type 2 Diabetic Kidney Disease: A Multicenter Double-Blinded Randomized Placebo-Controlled Trial

PLoS ONE ◽

10.1371/journal.pone.0126027 ◽

2015 ◽

Vol 10 (5) ◽

pp. e0126027 ◽

Cited By ~ 25

Author(s):

Ping Li ◽

Yiping Chen ◽

Jianping Liu ◽

Jing Hong ◽

Yueyi Deng ◽

...

Keyword(s):

Kidney Disease ◽

Diabetic Kidney Disease ◽

Controlled Trial ◽

Efficacy And Safety ◽

Diabetic Kidney ◽

Double Blinded ◽

Tangshen Formula ◽

Type 2 Diabetic

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Exercise Ameliorates Diabetic Kidney Disease in Type 2 Diabetic Fatty Rats

Antioxidants ◽

10.3390/antiox10111754 ◽

2021 ◽

Vol 10 (11) ◽

pp. 1754

Author(s):

Itaru Monno ◽

Yoshio Ogura ◽

Jing Xu ◽

Daisuke Koya ◽

Munehiro Kitada

Keyword(s):

Kidney Disease ◽

Diabetic Kidney Disease ◽

Molecular Mechanisms ◽

Kidney Injury ◽

Male Rats ◽

Fatty Acid Binding ◽

Diabetic Kidney ◽

Beneficial Effects ◽

Type 2 Diabetic

Lifestyle improvement, including through exercise, has been recognized as an important mode of therapy for the suppression of diabetic kidney disease (DKD). However, the detailed molecular mechanisms by which exercise exerts beneficial effects in the suppression of DKD have not yet been fully elucidated. In this study, we investigate the effects of treadmill exercise training (TET) for 8 weeks (13 m/min, 30 min/day, 5 days/week) on kidney injuries of type 2 diabetic male rats with obesity (Wistar fatty (fa/fa) rats: WFRs) at 36 weeks of age. TET significantly suppressed the levels of albuminuria and urinary liver-type fatty-acid-binding protein (L-FABP), tubulointerstitial fibrosis, inflammation, and oxidative stress in the kidneys of WFRs. In addition, TET mitigated excessive apoptosis and restored autophagy in the renal cortex, as well as suppressed the development of morphological abnormalities in the mitochondria of proximal tubular cells, which were also accompanied by the restoration of AMP-activated kinase (AMPK) activity and suppression of the mechanistic target of rapamycin complex 1 (mTORC1). In conclusion, TET ameliorates diabetes-induced kidney injury in type 2 diabetic fatty rats.

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Chinese herbal medicine Tangshen Formula Treatment For Type 2 Diabetic Kidney Disease in Early Stage : study protocol for a randomized controlled trial

10.21203/rs.2.11806/v1 ◽

2019 ◽

Author(s):

De Jin ◽

Wen-Jing Huang ◽

Xiang Meng ◽

Fan Yang ◽

Qi Bao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Kidney Disease ◽

Diabetic Kidney Disease ◽

Early Stage ◽

Controlled Trial ◽

Randomized Controlled ◽

Chinese Herbal ◽

Tangshen Formula ◽

Type 2 Diabetic

Abstract Abstract Background: Diabetic kidney disease (DKD) is the main cause of end stage kidney disease(ESKD) and It has become a heavy economic and social burden due to its high prevalence and morbidity. However, the current therapies for DKD are not entirely perfect. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed the Chinese herbal Tangshen Formula(TSF) may delay the progression of DKD, reducing micro-and macro-albuminuria, improving renal function. This trial was conducted to assess the effectiveness and safety of TSF used in combination with conventional treatment. Methods/design: We are implementing a randomized, placebo-controlled, multicenter, clinical trial as a means of evaluating the effectiveness and safety of TSF. 623 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus Losartan) and a control group (placebo plus Losartan). The trial cycle lasts 24 weeks. The primary outcome will be changes in ACR from baseline to 24 weeks between the two groups and ACR will be compared at baseline and treatment endpoint in each group. The secondary outcome will be changes in the ratio of progression into the clinical proteinuria period after intervention, Urine micro albumin negative conversion rate, the ratio of normal urinary micro albumin, doubling rate of baseline creatinine value and GFR between the two groups. Safety in medication will also be evaluated. Discussion: We hypothesize that type 2 diabetic patients in early stage of DKD will benefit from TSF. If successful, this study will provide an evidence-based complementary remedies for delaying the progression of DKD. Trial registration: ClinicalTrials.gov (NCT03009864) Keywords: Diabetes Kidney Disease, Traditional Chinese medicine, Treatment, Clinical trials，Randomized controlled trial

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Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3821-6 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

De Jin ◽

Wen-Jing Huang ◽

Xiang Meng ◽

Fan Yang ◽

Qi Bao ◽

...

Keyword(s):

Kidney Disease ◽

Diabetic Kidney Disease ◽

Early Stage ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Chinese Herbal ◽

Be The Change ◽

Tangshen Formula

Abstract Background Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed that the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing microalbuminuria and macroalbuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD. Methods/design This trial is a 13-center, randomized, double-blind, placebo-controlled study. A total of 632 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus losartan) and a control group (placebo plus losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in the urine microalbumin–creatinine ratio from baseline to week 24. The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups. Safety in medication will also be evaluated. Discussion We hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration ClinicalTrials.gov, NCT03009864. Registered January 2017.

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