FC 092EFFECT OF GEMIGLIPTIN ON BIOMARKERS OF KIDNEY INJURY AND VASCULAR CALCIFICATION IN DIABETIC NEPHROPATHY: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Thananda Trakarnvanich ◽  
Bancha Satirapoj ◽  
Swangjit Suraamornkul ◽  
Thanit Chiranantawat ◽  
Anoma Sanpatchayapong ◽  
...  
Keyword(s):  
Diabetic Nephropathy ◽  
Vascular Calcification ◽  
Controlled Trial ◽  
Vascular Inflammation ◽  
Kidney Injury ◽  
Calcium Score ◽  
Coronary Calcification ◽  
Control Group ◽  
Fatty Acid Binding ◽  
Dipeptidyl Peptidase 4

Abstract Background and Aims Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients. Method This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months. Results Overall 182 patients completed the study. Significantly reductions in hemoglobinA1C level were seen at month 6 with gemigliptin group (-0.67%) vs. control group (-0.15%; P=0.048). Changes of CAC score, CAVI, estimated GFR and proteinuria did not significantly difference in the both groups during 6 months of study. However, biomarkers of vascular calcification including serum bone alkaline phosphatase and biomarkers of kidney injury including urine neutrophil gelatinase-associated lipocalin (NGAL)/Cr and urine liver fatty acid-binding protein (L-FABP)/Cr improved significantly after gemigliptin treatment when compared to the control group. No serious adverse event was found during study. Conclusion Our study shows that gemigliptin has significant benefits on biomarkers of renal tubular injury and vascular calcification in patients with diabetic nephropathy, but gemigliptin does not affect on renal function and coronary calcification compared with control. The larger and longer follow-up will be essential to determine these beneficial effects.

scholarly journals Effect of Dipeptidyl Peptidase- 4 (DPP-4) Inhibitor on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Thananda Trakarnvanich ◽  
Bancha Satirapoj ◽  
Sawangjit Suraamornkul ◽  
Thanit Chiranantawat ◽  
Anoma Sanpatchayapong ◽  
...  
Keyword(s):  
Diabetic Nephropathy ◽  
Vascular Calcification ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Calcium Score ◽  
Coronary Calcification ◽  
Dipeptidyl Peptidase ◽  
Control Group ◽  
Fatty Acid Binding ◽  
Dipeptidyl Peptidase 4

Abstract Introduction: Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and have pleiotropic effects on kidney injury, albuminuria and vascular inflammation, especially in animal models. We plan to evaluate the effects of a potent DPP4 inhibitor (gemigliptin) on these processes in diabetic nephropathy patients.Methods: This was a multicenter, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to a group treated with 50 mg gemigliptin daily with standard care of diabetes mellitus for 6 months. The changes in coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), vascular calcification and tubular renal injury markers were evaluated at baseline and 6 months.Results: In total, 182 patients completed the study. Significant reductions in hemoglobin A1C levels were observed in both groups. The changes in CAC score, CAVI, estimated GFR and proteinuria over the 6 months of the study did not significantly differ between the groups. However, biomarkers of vascular calcification, including serum bone alkaline phosphatase, and kidney injury, including urine neutrophil gelatinase-associated lipocalin (NGAL)/Cr and urine liver fatty acid-binding protein (L-FABP)/Cr, were improved significantly in the gemigliptin treatment group compared to the control group. No serious adverse event was observed during the study.Conclusion: Our study shows that gemigliptin significantly improves renal tubular injury biomarkers and vascular calcification in patients with diabetic nephropathy; however, gemigliptin does not affect renal function or coronary calcification compared with the control. A larger and longer follow-up will be essential to determine these beneficial effects.Clinical trialsClinicalTrials.Gov Identifier: NCT04705506

scholarly journals Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Thananda Trakarnvanich ◽  
Bancha Satirapoj ◽  
Swangjit Suraamornkul ◽  
Thanit Chirananthavat ◽  
Anoma Sanpatchayapong ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Vascular Calcification ◽  
Diabetic Kidney Disease ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Dipeptidyl Peptidase ◽  
Control Group ◽  
Fatty Acid Binding ◽  
Diabetic Kidney ◽  
Dipeptidyl Peptidase 4

Introduction. Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and have pleiotropic effects on kidney injury, albuminuria, and vascular inflammation, especially in animal models. We evaluated the effects of a potent DPP4 inhibitor (gemigliptin) on these processes among patients with diabetic kidney disease (DKD). Methods. This study employed a multicenter, prospective, randomized, placebo-controlled design. A total of 201 participants were enrolled and randomly assigned to one of two groups, one received treatment with 50 mg gemigliptin daily along with standard care for diabetes mellitus for 6 months. The changes in the coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (eGFR), vascular calcification level, and tubular renal injury marker expression were evaluated at baseline and 6 months. Results. In total, 182 patients completed the study. Significant reductions in hemoglobin A1C levels were observed in both groups. The changes in the CAC score, CAVI, eGFR, and level of proteinuria over the 6 months of the study did not significantly differ between the gemigliptin and control groups. However, biomarkers of vascular calcification, including serum bone alkaline phosphatase and kidney injury, including urine neutrophil gelatinase-associated lipocalin (NGAL)/Cr and urine liver fatty acid-binding protein (L-FABP)/Cr, were improved significantly in the gemigliptin treatment group compared with the control group. No serious adverse events were observed during the study. Conclusion. Our study showed that gemigliptin significantly improved the expression of renal tubular injury biomarkers and vascular calcification levels among patients with DKD; however, gemigliptin did not affect renal function or coronary calcification compared with those observed in the control. A larger study with a longer follow-up is essential to verify these beneficial effects. Clinical Trials. This trial is registered with ClinicalTrials.Gov Identifier NCT04705506.

scholarly journals Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Qiong-Fang Wu ◽  
Hao Kong ◽  
Zhen-Zhen Xu ◽  
Huai-Jin Li ◽  
Dong-Liang Mu ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Partial Nephrectomy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kidney Injury ◽  
Control Group ◽  
Hemodynamic Management ◽  
Randomized Controlled ◽  
Renal Hilum ◽  
Pilot Randomized Controlled Trial

Abstract Background The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management may reduce AKI in patients following partial nephrectomy. Methods This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0–4.0 L/min/m2 and mean arterial pressure > 95 mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days. Results From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72; control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28–1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups. Conclusion For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results. Trial registration Clinicaltrials.gov identifier: NCT02803372. Date of registration: June 6, 2016.

scholarly journals Electrolytes supplementation can decrease the risk of nephrotoxicity in patients with solid tumors undergoing chemotherapy with cisplatin

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Omary M. S. Minzi ◽  
Tatu E. Lyimo ◽  
Francis F. Furia ◽  
Alphonce I. Marealle ◽  
Manase Kilonzi ◽  
...  
Keyword(s):  
Treatment Group ◽  
Serum Creatinine ◽  
Solid Tumors ◽  
Normal Saline ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Rank Test ◽  
Control Group ◽  
Relative Risks ◽  
Kaplan Meier

Abstract Background Cisplatin is an important drug in the treatment of various Cancers. However, this drug causes nephrotoxicity that is linked to electrolyte derangement. The aim of this study was to evaluate the effect of electrolyte supplementation in reducing kidney injury in patients receiving cisplatin-based regimen. Methods This was non-randomized interventional study conducted at Ocean Road Cancer Institute (ORCI) among patients with confirmed solid tumors. Patients who received cisplatin-based chemotherapy at a dose of ≥50 mg with intravenous normal saline supplemented with Magnesium, Calcium and Potassium (triple electrolyte supplementation) were compared with those who received cisplatin-based chemotherapy with normal saline alone. The patients were followed up for 4 weeks and serum creatinine was measured at every visit. Nephrotoxicity was defined as serum creatinine elevation > 1.5 times that at baseline. Results A total of 99 patients were recruited, whereby 49 patients (49.5%) received electrolyte supplementation (treatment group) and 50 patients (51.5%) did not receive electrolyte supplementation (control group). The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group. Patients in the control group were 2.6 times more likely to experience nephrotoxicity as compared to treatment group [Relative Risks (RR); 2.6, 95%CI; 1.5–4.9, P < 0.0001]. The most common malignancy was cervical cancer, n = 43 (87.8%) in treatment group and n = 45 (90.0%) in the control group (P = 0.590). The Kaplan-Meier analysis and the log-rank test revealed that electrolytes supplementation was associated with extended survival with less nephrotoxicity incidences [P = 0.0004; Hazard ratio (HR) 0.3149; 95% CI 0.165 to 0.6011]. Conclusions Electrolytes supplementation decreases the risk of nephrotoxicity after chemotherapy with cisplatin. A randomized controlled trial with a larger sample size is recommended to evaluate the robustness of these findings.

scholarly journals Evaluation of urinary L-FABP as an early marker for diabetic nephropathy in type 2 diabetic patients

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Duong Thi Thuy Ngan ◽  
Nguyen Gia Binh ◽  
Le Thi Huong Lan ◽  
Cuc Thi Thu Nguyen ◽  
Phung Thanh Huong
Keyword(s):  
Renal Function ◽  
Diabetic Nephropathy ◽  
Early Detection ◽  
Urinary Albumin ◽  
Control Group ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Fatty Acid Binding ◽  
Type 2 Diabetic

Summary Background Albuminuria is the standard biomarker for the diagnosis of diabetic nephropathy (DN). However, some patients with persistent microalbuminuria still progress to chronic kidney disease, raising the question of finding a better biomarker. This study aimed to evaluate the correlation of urinary liver-type fatty acid-binding protein (L-FABP) levels with renal function and to compare the role of urinary albumin-to-creatinine ratio (ACR) with urinary L-FABP in early detection of DN in type 2 diabetic patients. Methods The cross-sectional study was done on 106 type 2 diabetic patients and 30 non-diabetic people. L-FABP was measured with the Latex enhanced immunoturbidimetric technique. Results There was a strong and negative correlation between the urine L-FABP levels and eGFR (r = -0.606, p<0.001). The urinary L-FABP levels were significantly higher (p<0.001) in the normoalbuminuria diabetic group than the non-diabetic control group. The ROC-curve analyses in the diabetic patients and the normoalbuminuria diabetic patients showed that the AUCL-FABP was remarkably higher (p<0.001) than the AUCACR. An optimal cutoff value of 5 mg L-FABP/g Cr (with the sensitivity of 98.1% and specificity of 90%) and of 4.3 mg L-FABP/g Cr (with the sensitivity of 100% and specificity of 86.67%) was set to detect DN in the diabetic patients and the normoalbuminuria diabetic patients, respectively. Conclusions The change in urinary L-FABP levels happened earlier than in urinary albumin during renal function impairment. Urinary L-FABP can be used as a better indicator than ACR for early detection of DN in type 2 diabetes.

scholarly journals Electroacupuncture Improves Intestinal Dysfunction in Septic Patients: A Randomised Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Jian-biao Meng ◽  
Yan-na Jiao ◽  
Geng Zhang ◽  
Xiu-juan Xu ◽  
Chun-lian Ji ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Treatment Group ◽  
Length Of Stay ◽  
Inflammatory Reaction ◽  
Plasma Levels ◽  
Controlled Trial ◽  
Control Group ◽  
Protective Effects ◽  
Fatty Acid Binding ◽  
Quantitative Score

Objective. To investigate the effects of electroacupuncture (EA) at “Zusanli” (ST36) and “Shangjuxu”(ST37) on reducing inflammatory reaction and improving intestinal dysfunction in patients with sepsis-induced intestinal dysfunction with syndrome of obstruction of the bowels Qi. Methods. A total of 71 patients with sepsis-induced intestinal dysfunction with syndrome of obstruction of the bowels Qi were randomly assigned to control group (n=36) and treatment group (n=35). Patients in control group were given conventional therapies including fluid resuscitation, anti-infection, vasoactive agents, mechanical ventilation, supply of enteral nutrition, and glutamine as soon as possible. In addition to conventional therapies, patients in treatment group underwent 20 minutes of EA at ST36-ST37 twice a day for five days. At baseline, day 1, day 3, and day 7 after treatment, the plasma levels of procalcitonin (PCT), tumor necrosis factor-α (TNF-α), intestinal fatty acid-binding proteins (I-FABP), D-lactate, citrulline, and TCM quantitative score of intestinal dysfunction were measured and recorded, respectively. And days on mechanical ventilation (MV), length of stay in intensive care unit (ICU), and 28d mortality were recorded. Results. During treatment, the plasma levels of PCT, TNF-α, I-FABP, D-lactate, and TCM quantitative score of intestinal dysfunction were declining in both groups, while the treatment group showed a significant decline (P<0.05). Plasma levels of citrulline were increasing in both groups, while the treatment group showed a significant increase (P<0.05). However, there were no significant differences in the days on MV, length of stay in ICU, and 28d mortality between two groups (P>0.05). Conclusions. EA at ST36-ST37 can reduce inflammatory reaction and has protective effects on intestinal function in patients with sepsis-induced intestinal dysfunction with syndrome of obstruction of the bowels Qi. Trial Registration. This trial was registered at http://www.chictr.org.cn/(ChiCTR-IOR-17010910).

scholarly journals Effect of a 3% gelatin solution on urinary KIM-1 levels in patients after thyroidectomy: a preliminary randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Patrycja Leśnik ◽  
Ewa Woźnica-Niesobska ◽  
Jarosław Janc ◽  
Magdalena Mierzchała-Pasierb ◽  
Lidia Łysenko
Keyword(s):  
Kidney Function ◽  
Controlled Trial ◽  
Demographic Data ◽  
Kidney Injury ◽  
Tissue Perfusion ◽  
Study Groups ◽  
Study Data ◽  
Control Group ◽  
Gelatin Solution ◽  
Significant Difference

AbstractOptimal fluid therapy significantly affects the maintenance of proper tissue perfusion and, consequently, kidney function. An adverse effect of colloids on kidney function is related to the incidence of postoperative kidney failure. The study aimed to assess the effect of a 3% gelatin solution on kidney function based on the urinary kidney injury molecule-1 (uKIM-1) level. This study used a parallel design and enrolled 64 adult patients with a mean age of 52.5 ± 13.1 years, all of whom underwent a thyroidectomy procedure under general anesthesia. Patients were randomly assigned to three comparison groups, each receiving a different dose of 3% gelatin solution during the thyroidectomy procedure. The patients from study groups A (n = 21) and B (n = 21) received a 3% gelatin solution at a dose of 30 ml/kg and 15 ml/kg body weight, respectively, during the first hour of the procedure. The patients from the control group C (n = 22) received an isotonic multi-electrolyte solution. Serum creatinine levels were determined, and urine samples were collected to determine levels of uKIM-1 before, 2 h, and 24 h after surgery. The patients’ demographic data, type and volume of fluid and hemodynamic status during the surgery were collected from relevant anesthesia protocols and were included in the study data. There were no statistically significant changes between groups in hemodynamic parameters such as systolic and diastolic blood pressure, heart rate, and oxygen saturation values. A statistically significant increase in uKIM-1 level was noted in patients receiving the 3% gelatin solution regardless of the dose. A statistically significant difference in uKIM-1 level was observed between groups A, B, and C measured 24 h after surgery, with the highest uKIM-1 level in group A. Measurement of uKIM-1 level could be an early and sensitive biomarker of kidney injury. Kidney toxicity of a 3% gelatin solution, evaluated based on the level of uKIM-1 in urine, correlates with transfused fluid volume. This study was retrospectively registered in the ISRCTN clinical trials registry (ISRCTN73266049, 08/04/2021: https://www.isrctn.com/ISRCTN73266049).

scholarly journals Impact of Goal-directed Hemodynamic Management on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Qiong-Fang Wu ◽  
Hao Kong ◽  
Zhen-Zhen Xu ◽  
Huai-Jin Li ◽  
Dong-Liang Mu ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Partial Nephrectomy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kidney Injury ◽  
Control Group ◽  
Hemodynamic Management ◽  
Randomized Controlled ◽  
Renal Hilum ◽  
Pilot Randomized Controlled Trial

Abstract Background: The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management could reduce AKI in patients following partial nephrectomy. Methods: This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0 - 4.0 L/min/m2 and mean arterial pressure > 95mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days. Results: From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72, control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28-1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups.Conclusion: For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results.Trial registration: Clinicaltrials.gov identifier: NCT02803372. Date of registration: June 6, 2016.

scholarly journals Evaluation of a Multi-disciplinary Medical Model in Vancomycin Treatment in Chinese Adult Patients: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Lingyun Ma ◽  
Ying Zhou ◽  
Chaoyang Chen ◽  
Feifei Gao ◽  
Xueying Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Medical Model ◽  
Kidney Injury ◽  
Outcome Analysis ◽  
Control Group ◽  
Large Sample Size ◽  
Open Label ◽  
Mortality And Morbidity ◽  
Chinese Adult

Abstract Background Acute kidney injury (AKI) is a common adverse drug reaction of vancomycin which is associated with increased mortality and morbidity. To investigate the roles of a multi-disciplinary medical model in preventing vancomycin-induced AKI (VI-AKI) through a standardized clinical path. Methods This study was a single center open-label randomized clinical trial which included adult pneumonia patients using vancomycin in Peking University First Hospital. In the intervention group (multi-disciplinary medical model), a standardized clinical path was conducted as (1) pharmacists-driven PopPK formula-based vancomycin regimen. (2) pharmacists-driven TDM monitor. (3) physicians-driven SCr monitor. (4) nephrologists-driven multi-disciplinary kidney protection. Pharmacists or nephrologists did not intervene patients; treatment in the control group (routine medical model). The primary outcome was the incidence of VI-AKI. Results145 patients including 72 in the intervention arm and 73 in the control arm, aged 69.0 (60.0-79.0) years with male in 74.5%, were included in the outcome analysis. The incidence of AKI was 23.6% (17/72) in the intervention arm and 34.2% (25/73) in the control arm (P=0.16). Among the 57 patients in the intervention arm who accepted PopPK based vancomycin regimen, AKI incidence was significantly decreased compared to patients in the control arm (15.8% vs. 34.2%, P=0.02). Conclusions Intervention with a multi-disciplinary medical model through standardized clinical path has the potential to reduce the incidence of VI-AKI. Multicenter and large sample size studies are warranted. This trial is registered with chictr.org (number ChiCTR1900021115, http://www.chictr.org.cn/edit.aspx?pid=35376&htm=4) on 29th Jan 2019 by retrospective registration.

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