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Abstract Context Although adding spironolactone to renin-angiotensin system blockers reduces albuminuria in adults with chronic kidney disease and type 2 diabetes, it increases the risk of hyperkalemia. Objective To assess whether a lower dose of spironolactone (12.5 mg/d) reduces the risk of hyperkalemia while maintaining its effect on reducing albuminemia. Design Multicenter, open-label, randomized controlled trial. Setting This study was conducted from July 2016 to November 2020 in ambulatory care at 3 diabetes medical institutions in Japan. Patients We enrolled 130 Japanese adults with type 2 diabetes and albuminuria (≥30 mg/gCre), estimated glomerular filtration rate ≥30 mL/min/1.73 m2, and serum potassium level <5.0 mEq/L. Interventions The participants were randomly assigned to the spironolactone-administered and control groups. Main outcome measures Changes in urine albumin-to-creatinine ratio (UACR) from baseline over the 24-week interventional period. Results The spironolactone group showed a significant reduction in UACR from baseline (mean decrease, 103.47 ± 340.80 mg/gCre) compared with the control group, which showed an increased UACR (mean increase, 63.93 ± 310.14 mg/gCre; P = .0007, Wilcoxon rank-sum test and t test). Although the spironolactone group had a statistically significant increase in serum potassium levels, none of the participants had a potassium level ≥5.5 mEq/L at 24 weeks. Further, participants with a higher initial serum potassium level tended to have a smaller increase (estimate, −0.37, analysis of covariance). Conclusions Low-dose spironolactone administration reduced albuminuria without causing hyperkalemia. Spironolactone administration, the oldest known and most cost-effective mineralocorticoid receptor antagonist, at lower doses should be reconsidered.

There are few established easy-to-perform exercise protocols with evidence-based effects for individuals with type 2 diabetes (T2D). A unique exercise regimen, interval walking training (IWT), has been reported to be beneficial for improving metabolic function, physical fitness and muscle strength in adults of overall health. This pilot study aims to demonstrate descriptive statistics of IWT adherence and changes in various data before and after the intervention of IWT in adults with T2D, perform statistical hypothesis testing, and calculate effect sizes. We performed a single-arm interventional pilot study with IWT for 20 weeks. We enrolled 51 participants with T2D aged 20–80 years with glycohemoglobin (HbA1c) levels of 6.5–10.0% (48–86 mmol/mol) and a body mass index of 20–34 kg/m 2 , respectively. The target was 60 min/week of fast walking for 20 weeks. The participants visited the hospital and were examined at 4-week intervals during this period. Between the start of IWT and after 20 weeks, we measured and evaluated changes in glucose and lipid metabolism data, body composition, physical fitness, muscle strength, dietary calorie intake, and daily exercise calories. All included participants completed IWT, with 39% of them reaching the target length of fast walking over 1,200 minutes in 20 weeks. In the primary outcome, HbA1c levels, and in the secondary, lipid metabolism and body composition, no significant changes were observed except for high-density lipoprotein cholesterol (HDL-C) (from 1.4 mmol/L to 1.5 mmol/L, p = 0.0093, t-test). However, in the target achievement group, a significant increase in VO 2 peak by 10% (from 1,682 mL/min to 1,827 mL/min, p = 0.037, t-test) was observed. Effect sizes were Cohen’s d = 0.25 of HDL-C, -0.55 of triglyceride, and 0.24 of VO 2 peak in the target achievement group, which were considered to be of small to medium clinical significance. These results could be solely attributed to IWT since there were no significant differences in dietary intake and daily life energy consumption before and after the study. IWT could be highly versatile and was suggested to have a positive effect on lipid metabolism and physical fitness. In future randomized controlled trial (RCT) studies, the detailed effects of IWT, focusing on these parameters, will be examined. Trial registration: This trial was registered with the Japanese University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: Usefulness on interval walking training in patients with type 2 diabetes. 000037303 ).

Background/Aim: Appropriate dietary assessment plays a crucial role in individualized nutritional therapy for individuals with type 2 diabetes mellitus (T2DM). Daily dietary variations must be considered in the estimation of usual dietary intake, and such data are limited in individuals with T2DM. This study aimed to evaluate within- and between-individual variations in protein, sodium, potassium, and phosphorus intakes estimated from 24 h urine collection (24 h UC) and semi-weighted dietary records (DRs) in Japanese individuals with T2DM. Methods: This study included 39 Japanese individuals (26 males, 13 females; mean age 64.6 years) with T2DM who attended two hospitals. Protein, sodium, potassium, and phosphorus intakes were estimated using 2-day 24 h UC and 3-day DRs and within- and between-individual variations were calculated using a one-way analysis of variance. Results: The mean protein, potassium, and phosphorus intakes did not significantly differ between 24 h UC and DRs. However, sodium intake was lower when estimated by DRs than by 24 h UC. The coefficients of within-individual variation (CVw) differed between 24 h UC and DRs. For protein and phosphorus, the CVw values were smaller by 12.5% and 8.0% in males and 2.3% and 3.0% in females, respectively, for 24 h UC than DRs. For sodium and potassium, the CVw values were smaller by 7.0% and 4.8% in males, but larger by 5.0% and 3.3% in females, respectively, for 24 h UC than DRs. Conclusions: Our findings demonstrated that 24 h UC showed smaller within-individual variations than DRs for protein and phosphorus in both sexes, with sex-specific differences for sodium and potassium.

We previously reported the efficacy and safety of low-dose (12.5 mg/day) spironolactone for chronic kidney disease (CKD) with diabetes. Few studies have examined the characteristics of patients who may have reduced urinary albumin-creatinine ratio (UACR) on mineralocorticoid receptor antagonists. In this study, we aimed to identify the clinical characteristics of patients prone to benefit from UACR reduction with low-dose spironolactone.INTRODUCTIONWe previously reported the efficacy and safety of low-dose (12.5 mg/day) spironolactone for chronic kidney disease (CKD) with diabetes. Few studies have examined the characteristics of patients who may have reduced urinary albumin-creatinine ratio (UACR) on mineralocorticoid receptor antagonists. In this study, we aimed to identify the clinical characteristics of patients prone to benefit from UACR reduction with low-dose spironolactone.This was a post-hoc analysis of a previous trial and included 55 patients assigned to the spironolactone group. Univariate regression analysis was performed to determine the association between the change in UACR after 24 weeks of low-dose spironolactone administration and baseline exploratory parameters. Multiple regression analysis was conducted on the associated parameters, and regression models were created for analysis. A similar analysis was performed for changes in serum potassium levels and estimated glomerular filtration rate (eGFR) after 24 weeks of spironolactone administration.METHODSThis was a post-hoc analysis of a previous trial and included 55 patients assigned to the spironolactone group. Univariate regression analysis was performed to determine the association between the change in UACR after 24 weeks of low-dose spironolactone administration and baseline exploratory parameters. Multiple regression analysis was conducted on the associated parameters, and regression models were created for analysis. A similar analysis was performed for changes in serum potassium levels and estimated glomerular filtration rate (eGFR) after 24 weeks of spironolactone administration.In the univariate analysis, baseline UACR, triglyceride levels, and eGFR were associated with changes in UACR. The regression coefficient estimates were significant for baseline UACR, triglyceride levels, and eGFR (p = 0.002, 0.017, and 0.003, respectively). The reduction in UACR was greater with higher baseline UACR and triglyceride levels, and lower baseline eGFRs. The increase in serum potassium levels due to low-dose spironolactone administration showed a negative correlation with baseline serum potassium levels and no correlation with baseline eGFR, suggesting its safety.RESULTSIn the univariate analysis, baseline UACR, triglyceride levels, and eGFR were associated with changes in UACR. The regression coefficient estimates were significant for baseline UACR, triglyceride levels, and eGFR (p = 0.002, 0.017, and 0.003, respectively). The reduction in UACR was greater with higher baseline UACR and triglyceride levels, and lower baseline eGFRs. The increase in serum potassium levels due to low-dose spironolactone administration showed a negative correlation with baseline serum potassium levels and no correlation with baseline eGFR, suggesting its safety.It may not be too late to start treatment with low-dose spironolactone, even in patients with relatively advanced CKD with diabetes.CONCLUSIONSIt may not be too late to start treatment with low-dose spironolactone, even in patients with relatively advanced CKD with diabetes.

We previously reported the efficacy and safety of low-dose (12.5 mg/day) spironolactone for chronic kidney disease (CKD) with diabetes. Few studies have examined the characteristics of patients who may have reduced urinary albumin-creatinine ratio (UACR) on mineralocorticoid receptor antagonists. In this study, we aimed to identify the clinical characteristics of patients prone to benefit from UACR reduction with low-dose spironolactone. This was a post hoc analysis of a previous trial and included 55 patients assigned to the spironolactone group. Univariate regression analysis was performed to determine the association between the change in UACR after 24 weeks of low-dose spironolactone administration and baseline exploratory parameters. Multiple regression analysis was conducted on the associated parameters, and regression models were created for analysis. A similar analysis was performed for changes in serum potassium levels and estimated glomerular filtration rate (eGFR) after 24 weeks of spironolactone administration. In the univariate analysis, baseline UACR, triglyceride levels, and eGFR were associated with changes in UACR. The regression coefficient estimates were significant for baseline UACR, triglyceride levels, and eGFR (p = 0.002, 0.017, and 0.003, respectively). The reduction in UACR was greater with higher baseline UACR and triglyceride levels, and lower baseline eGFRs. The increase in serum potassium levels due to low-dose spironolactone administration showed a negative correlation with baseline serum potassium levels and no correlation with baseline eGFR, suggesting its safety. It may not be too late to start treatment with low-dose spironolactone, even in patients with relatively advanced CKD with diabetes.

Disclosure: A. Oiwa: None. D. Hiwatashi: None. T. Takeda: None. T. Miyamoto: None. I. Kawata: None. M. Koinuma: None. S. Kubota: None. S. Takayama: None. M. Yamazaki: None. M. Komatsu: None. Objective: To evaluate the albuminuria-lowering effect and safety regarding hyperkalemia of adding low-dose spironolactone (12.5 mg/day) to the renin-angiotensin system (RAS) blockers in adults with chronic kidney disease and type 2 diabetes. Research Design and Methods: This was a multicenter, open-label, randomized controlled trial. We enrolled 130 Japanese individuals aged ≥20 years with type 2 diabetes and albuminuria (≥30 mg/gCre), estimated glomerular filtration ≥30 mL/min/1.73 m2, and serum potassium level <5.0 mEq/L. They were randomly assigned to the spironolactone-administered and control groups. The main outcomes were changes in urine albumin-to-creatinine ratio (UACR), serum potassium levels and renal function from baseline to the 24-week interventional period. Results: The spironolactone-administered group showed a significant reduction in UACR by a mean of 103.47 ± 340.80 mg/gCre from baseline compared with the control group that showed increased UACR by a mean of 63.93 ± 310.14 mg/gCre (p = 0.0007, Wilcoxon rank-sum test and T-test). As for serum potassium levels, although there was a statistically significant increase (p = 0.0026), none of the participants had a potassium level ≥5.5 mEq/L at 24 weeks. Further, there was a tendency that the higher the initial potassium level, the smaller the increase in serum potassium level (estimate −0.37, analysis of covariance). Conclusions: This study first demonstrated that low-dose spironolactone administration reliably reduced albuminuria and was safe against hyperkalemia. The administration of spironolactone, which is the oldest known and most cost-effective of all the other mineralocorticoid receptor antagonists, should be re-evaluated with consideration of lower doses. Presentation: Thursday, June 15, 2023

P-272 Key Words: Arterial Stiffness, Arterial Stiffness Index, Arteriosclerosis

Arterial Stiffness Index (ASI) is a novel quantitative estimate directly calculated from the relation between transmural pressure and arterial volumetric change. Functional changes in arterial stiffness have been investigated by pulse wave velocity (PWV). However, these measures have limitations for clinical application because of their dependence on arterial pressure. In the present study, to test the ability for ASI to act as a marker of arteriosclerosis, we determined and compared the distensibility of brachial artery in normotensive non-diabetic subjects with those in subjects with hypertension(HT) and/or diabetes mellitus(DM). Data of 231 subjects were analyzed: men/women 111/120, the mean age 67 yrs, and BP 136 /78 mmHg. One hundred and thirty-four (61%) patients were hypertensive and were receiving antihypertensive drugs. Seventy-five (32%) patients were diabetic and were receiving oral hypoglycemic agents and/or insulin. ASI was obtained directly through computerized oscillometry (CardioVision, IMDP, Inc.). CardioVision utilizes the Oscillometric method of blood pressure measurement and generates information on the elasticity or flexibility of the brachial artery. To identify the variables correlated with ASI and PWV, multiple regression analysis was used. ASI was correlated with pulse pressure (PP) (beta=.579, p<.0001), mean blood pressure (MBP) (beta=-.208, p<.01), and the presence of HT (beta=.147, p<.03). PWV was correlated with MBP (beta=.460, p<.0001), age (beta=.334, p<.0001), body mass index (BMI) (beta=-.300, p<.0001) and PP (beta=.146, p<.05). ASI and PWV significantly increased with age. When ASI and PWV were plotted as a function of age, the regression line was significantly steeper in HT group than in non-HT group only for ASI. ASI was significantly higher in diabetic subjects than in non-diabetic subjects (mean +/- SE ; 102 +/− 8 vs. 134 +/− 13, p<0.05). ASI was significantly higher in subjects with both HT and DM than in subjects with HT or DM (mean +/- SE ; 153 +/− 16 vs. 114 +/− 11, p<0.05). Acceleration of age-related increase in arterial stiffness in subjects with hypertension was detectable by ASI, but not by PWV. Furthermore, HT-related arterial stiffness was enhanced in subjects with diabetes mellitus. Thus ASI provides reliable a quantitative measure of arterial stiffness. Am J Hypertens (2004) 17, 131A–131A; doi: 10.1016/j.amjhyper.2004.03.347