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The effectiveness of vitamin D3 supplementation in improving functional outcome of non-surgically treated symptomatic lumbar spinal stenosis: Randomized controlled clinical trial - Pilot study.
Ko, S, Kim, HC, Kwon, J
Medicine. 2023;(40):e32672
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Abstract
BACKGROUND Although vitamin D is one of the essential nutrients associated with musculoskeletal system function, there is no standard treatment method for vitamin D deficiency. This study aimed to investigate the effects of vitamin D supplementation on the improvement in symptoms, functional recovery of the spine, and changes in the quality of life in patients with spinal stenosis. METHODS In this prospective study, patients with spinal stenosis and serum 25-hydroxy vitamin D levels < 10 ng/mL were randomly assigned to a supplementation group (Group S) and a non-supplementation group (Group NS): 26 participants in Group S (16 females and 10 males) and 25 in Group NS (15 females and 10 males). The degree of lower back pain in both groups was assessed using the visual analog scale; spine function was assessed using the Oswestry disability index and Roland-Morris disability questionnaire; and patient quality of life was assessed using the 36-item short form health survey. We compared and analyzed the values that were measured at baseline, between 4 and 6 weeks (V1), 10 and 12 weeks (V2), and 22 and 26 weeks (V3). RESULTS No statistically significant difference was observed in lower back pain, spine function, or quality of life between both groups at baseline. In terms of lower back pain in V1, Group S scored 4.15 ± 3.12, while Group NS scored 5.64 ± 1.85 (P = .045). In V2, Group S scored 3.15 ± 2.38, while Group NS scored 4.52 ± 1.87 (P = .027). Moreover, in V3, Group S scored 3.58 ± 1.65, while Group NS scored 4.60 ± 1.68 (P = .033), indicating a statistically significant improvement in each period. CONCLUSION If a vitamin D deficiency that does not require surgical treatment exists in patients with lumbar spinal stenosis, high-dose vitamin D injections can improve lower back pain, which is the main symptom of lumbar spinal stenosis, as well as the functional outcomes of the spine and quality of life.
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A Comparison of the Pharmacokinetics and Safety of Dapagliflozin Formate, an Ester Prodrug of Dapagliflozin, to Dapagliflozin Propanediol Monohydrate in Healthy Subjects.
Kim, HC, Lee, S, Sung, S, Kim, E, Jang, IJ, Chung, JY
Drug design, development and therapy. 2023;:1203-1210
Abstract
BACKGROUND Dapagliflozin formate (DAP-FOR, DA-2811), an ester prodrug of dapagliflozin, was developed to improve the stability and pharmaceutical manufacturing process of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor. PURPOSE This study aimed to evaluate the pharmacokinetics (PKs) and safety of dapagliflozin for DAP-FOR compared to those for dapagliflozin propanediol monohydrate (DAP-PDH, Forxiga) in healthy subjects. METHODS This was an open-label, randomized, single-dose, two-period, two-sequence crossover study. The subjects received a single dose of DAP-FOR or DAP-PDH 10 mg in each period, with a 7-day washout. Serial blood samples for PK analysis were collected up to 48 hours after a single administration to determine plasma concentrations of DAP-FOR and dapagliflozin. PK parameters were calculated using a non-compartmental method and compared between the two drugs. RESULTS In total, 28 subjects completed the study. DAP-FOR plasma concentrations were not detected in all of the blood sampling time points except for one time point in one subject, and the corresponding DAP-FOR plasma concentration in the subject was close to the lower limit of quantification. The mean plasma concentration-time profiles of dapagliflozin were comparable between the two drugs. The geometric mean ratios and its 90% confidence intervals of the maximum plasma concentration and area under the plasma concentration-time curve of dapagliflozin for DAP-FOR to DAP-PDH were within the conventional bioequivalence range of 0.80-1.25. Both drugs were well-tolerated, with a similar incidence of adverse drug reactions. CONCLUSION The rapid conversion of DAP-FOR into dapagliflozin led to the extremely low exposure of DAP-FOR and comparable PK profiles of dapagliflozin between DAP-FOR and DAP-PDH. The safety profiles were also similar between the two drugs. These results suggest that DAP-FOR can be used as an alternative to DAP-PDH.
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Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.
Cho, SMJ, Lee, JH, Shim, JS, Yeom, H, Lee, SJ, Jeon, YW, Kim, HC
Journal of medical Internet research. 2020;22(10):e17435
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Metabolic disorders are established precursors to cardiovascular disease. The aim of the study was to evaluate the longitudinal effect of smartphone-based health care app on metabolic parameters in a sample of the general population with moderate metabolic abnormalities. The study is a single-blind 3-arm parallel-design randomized controlled trial delivering a 6-month primary prevention program via mobile app. One hundred twenty-nine smartphone users, aged between 30-59 years with at least 2 metabolic abnormalities, have been recruited. Results showed that the simultaneous diet/exercise logging and lifestyle coaching yielded greater body weight reduction, specifically via body fat mass reduction. On the other hand, the systolic blood pressure did not change notably between the 3 groups at any follow-up examinations. Authors conclude that future studies focusing on comparative effectiveness using alternative study designs are needed to integrate these apps in everyday lives and clinic practice.
Abstract
BACKGROUND Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications. OBJECTIVE We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting. METHODS In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat. RESULTS Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08). CONCLUSIONS Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention. TRIAL REGISTRATION ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.
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Desflurane versus sevoflurane in pediatric anesthesia with a laryngeal mask airway: A randomized controlled trial.
Kim, EH, Song, IK, Lee, JH, Kim, HS, Kim, HC, Yoon, SH, Jang, YE, Kim, JT
Medicine. 2017;(35):e7977
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Abstract
BACKGROUND Desflurane with a laryngeal mask airway may have advantages during ambulatory anesthesia. However, desflurane-induced airway irritability makes the use of desflurane challenging, especially in children. This study compared desflurane with sevoflurane maintenance anesthesia in terms of respiratory events and the emergence characteristics in children with a laryngeal mask airway. METHODS This randomized controlled trial evaluated 200 children undergoing strabismus surgery allocated to desflurane or sevoflurane groups. After inducing anesthesia with sevoflurane and thiopental sodium 5 mg kg, the anesthetic agent was changed to desflurane in the desflurane group, whereas sevoflurane was continued in the sevoflurane group. Respiratory events, emergence time, recovery time, and emergence agitation were compared between the groups. RESULTS The overall respiratory events did not differ between the groups. However, the incidence of mild desaturation (90% ≤ SpO2 < 97%) was significantly higher in the desflurane group (7%) than in the sevoflurane group (0%) (P = .007). Emergence was significantly faster in the desflurane group (6.6 ± 3.9 vs 8.0 ± 2.2 min, P = .003). The recovery time and emergence agitation in the postanesthesia care unit were comparable between groups. Laryngospasm developed in 5 children (1 in the sevoflurane group and 4 in the desflurane group, P = .365); of these, 4 patients were younger than 3 years. CONCLUSION Desflurane maintenance anesthesia in children with a laryngeal mask airway shows a similar rate of overall respiratory events compared with sevoflurane anesthesia. However, anesthesiologists should be cautious of using desflurane in younger children concerning desaturation events during emergence.
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Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.
Ha, CW, Park, YB, Choi, CH, Kyung, HS, Lee, JH, Yoo, JD, Yoo, JH, Choi, CH, Kim, CW, Kim, HC, et al
BMC musculoskeletal disorders. 2017;(1):223
Abstract
BACKGROUND This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. METHODS Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. RESULTS Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. CONCLUSIONS This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. TRIAL REGISTRATION ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.
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Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers.
Nam, Y, Lim, CH, Lee, HS, Chung, SJ, Chung, YH, Shin, YK, Kim, MG, Sohn, UD, Kim, HC, Jeong, JH
Clinical therapeutics. 2015;(2):302-10
Abstract
PURPOSE Amitriptyline is the most widely used tricyclic antidepressant (TCA). Although amitriptyline hydrochloride 10 and 25 mg has been marketed in Korea, no data on the dose proportionality of amitriptyline in Korean subjects are available. This clinical trial was designed to evaluate and compare the relative bioavailability with regard to dose proportionality between the two marketed strengths of amitriptyline hydrochloride tablets after a single-dose, oral administration under fasting conditions in healthy, male, Korean volunteers. METHODS This single-dose, randomized, open-label, 2-way crossover study was conducted in healthy male Korean subjects. Subjects were randomly assigned to 1 of 2 dose groups and received a single dose of 10 or 25 mg amitriptyline hydrochloride under fasting conditions, followed by the alternate dose in the subsequent study period. High performance liquid chromatography (HPLC)-mass spectrometry (MS)/MS detection was applied to determine plasma concentrations. Pharmacokinetic parameters were calculated, C(max), AUC(last), AUC(0-∞), t(½), and T(max). Statistical analysis was performed for the assessment of dose proportionality. Tolerability was assessed for up to 96 hours after administration. FINDINGS Twelve healthy Korean subjects completed this trial (mean [SD] age, 21.7 [1.9] years; height, 174.5 [5.0] cm; and weight, 66.7 [9.4] kg). Although 4 subjects experienced a total 5 adverse events (AEs), no serious AEs were reported during the study. The mean values of C(max) and AUC were proportional to the doses of 10 and 25 mg. The C(max), AUC(last), and AUC(0-∞) of amitriptyline hydrochloride 10 mg were 5.96 ng/mL, 91.35 ng·h/mL and 109.74 ng·h/mL, respectively. The C(max), AUC(last), and AUC(0-∞) of amitriptyline hydrochloride 25 mg were 17.69 ng/mL, 260.68 ng·h/mL, and 296.87 ng·h/mL, respectively. IMPLICATIONS Our results suggest that the 2 strengths of amitriptyline hydrochloride (10 and 25 mg) exhibited linear (dose-dependent) pharmacokinetics in these healthy, male, Korean subjects. Based on these results, a predictable and linear increase in systemic exposure can be expected. ClinicalTrials.gov identifier: NCT01367080.
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Model for assessing cardiovascular risk in a Korean population.
Park, GM, Han, S, Kim, SH, Jo, MW, Her, SH, Lee, JB, Lee, MS, Kim, HC, Ahn, JM, Lee, SW, et al
Circulation. Cardiovascular quality and outcomes. 2014;(6):944-51
Abstract
BACKGROUND A model for predicting cardiovascular disease in Asian populations is limited. METHODS AND RESULTS In total, 57 393 consecutive asymptomatic Korean individuals aged 30 to 80 years without a prior history of cardiovascular disease who underwent a general health examination were enrolled. Subjects were randomly classified into the train (n=45 914) and validation (n=11 479) cohorts. Thirty-one possible risk factors were assessed. The cardiovascular event was a composite of cardiovascular death, myocardial infarction, and stroke. In the train cohort, the C-index (95% confidence interval) and Akaike Information Criterion were used to develop the best-fitting prediction model. In the validation cohort, the predicted versus the observed cardiovascular event rates were compared by the C-index and Nam and D'Agostino χ(2) statistics. During a median follow-up period of 3.1 (interquartile range, 1.9-4.3) years, 458 subjects had 474 cardiovascular events. In the train cohort, the best-fitting model consisted of age, diabetes mellitus, hypertension, current smoking, family history of coronary heart disease, white blood cell, creatinine, glycohemoglobin, atrial fibrillation, blood pressure, and cholesterol (C-index =0.757 [0.726-0.788] and Akaike Information Criterion =7207). When this model was tested in the validation cohort, it performed well in terms of discrimination and calibration abilities (C-index=0.760 [0.693-0.828] and Nam and D'Agostino χ(2) statistic =0.001 for 3 years; C-index=0.782 [0.719-0.846] and Nam and D'Agostino χ(2) statistic=1.037 for 5 years). CONCLUSIONS A risk model based on traditional clinical and biomarkers has a feasible model performance in predicting cardiovascular events in an asymptomatic Korean population.
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Effects of neutral pH and low-glucose degradation product-containing peritoneal dialysis fluid on systemic markers of inflammation and endothelial dysfunction: a randomized controlled 1-year follow-up study.
Park, SH, Do, JY, Kim, YH, Lee, HY, Kim, BS, Shin, SK, Kim, HC, Chang, YK, Yang, JO, Chung, HC, et al
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2012;(3):1191-9
Abstract
BACKGROUND The local peritoneal effects of low-glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) have been extensively described. However, the systemic effects of prolonged prescription of these solutions are unknown. This study aimed to evaluate the effects of neutral pH and low-GDP PDF on systemic inflammation and endothelial dysfunction markers in peritoneal dialysis (PD) patients. METHODS This is a multicenter, open labeled, randomized controlled trial including one hundred fifty-two patients initiating continuous ambulatory peritoneal dialysis for end-stage renal disease from seven centers in Korea. Participants were randomly allocated to conventional PDF (Stay safe®; Fresenius Medical Care, Bad Homburg, Germany) or low-GDP PDF (Balance®; Fresenius Medical Care) and were followed for 1 year. Primary outcome variable was the inflammation and endothelial dysfunction index (IEDI), a composite score derived from serum levels of soluble intercellular adhesion molecule (sICAM)-1, soluble vascular cellular adhesion molecule (sVCAM)-1 and high-sensitivity C-reactive protein (hs-CRP). sICAM-1, sVCAM-1, residual renal function (RRF), peritoneal membrane transport characteristics, ultrafiltration volume and nutritional parameters were measured as secondary outcome variables. RESULTS Of 152 patients randomized, 146 (low-GDP: conventional PDF, 79:67) patients entered the trial (46% male, 53% with diabetes mellitus). At 12-month follow-up, the low-GDP group had significantly lower levels of IEDI, sICAM-1 and sVCAM-1 compared to the conventional group; hs-CRP was not different between groups. Peritoneal transport characteristics, RRF, nutritional parameters, incidence of peritonitis and death-censored technique survival were not different between groups. CONCLUSION Neutral pH and low-GDP PDF likely produce fewer changes in markers of endothelial dysfunction compared to conventional PDF in incident PD patients.
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Resistance exercise did not alter intramuscular adipose tissue but reduced retinol-binding protein-4 concentration in individuals with type 2 diabetes mellitus.
Ku, YH, Han, KA, Ahn, H, Kwon, H, Koo, BK, Kim, HC, Min, KW
The Journal of international medical research. 2010;(3):782-91
Abstract
Lipid accumulation in muscle is associated with diminished insulin sensitivity. It was hypothesized that resistance exercise decreases muscular adipose tissue and reduces the level of retinol-binding protein-4 (RBP4), which is linked to adipose tissue and insulin sensitivity in diabetics. Forty-four women with type 2 diabetes were randomly assigned to three groups for a period of 12 weeks: control (asked to maintain a sedentary lifestyle); resistance exercise (elastic band exercise at moderate intensity five times per week); and aerobic exercise (walking for 60 min at moderate intensity five times per week). Subcutaneous (SCAT), subfascial (SFAT) and intramuscular (IMAT) adipose tissues at mid-thigh level were assessed using computed tomography, and RBP4 level and insulin sensitivity (fractional disappearance rate of insulin, k(ITT)) were assessed before and after intervention. Changes in SCAT, SFAT, IMAT, RBP4 and k(ITT) were similar among the three groups. Within-group analysis revealed that body mass index and waist circumference decreased significantly in both exercise groups, but RBP4 decreased significantly only with resistance exercise. Resistance exercise did not alter muscular adipose tissue or improve insulin sensitivity.
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The effects of total energy expenditure from all levels of physical activity vs. physical activity energy expenditure from moderate-to-vigorous activity on visceral fat and insulin sensitivity in obese Type 2 diabetic women.
Koo, BK, Han, KA, Ahn, HJ, Jung, JY, Kim, HC, Min, KW
Diabetic medicine : a journal of the British Diabetic Association. 2010;(9):1088-92
Abstract
AIMS: We examined the effects of physical activity with or without dietary restriction for 3 months on regional fat and insulin sensitivity and compared the effect of total energy expenditure from all levels of physical activity with that of physical activity energy expenditure from moderate-to-vigorous exercise in obese women with Type 2 diabetes. METHODS In this randomized, controlled trial, we assessed change of body weight, abdominal visceral fat area, subcutaneous fat area and insulin sensitivity, expressed as K(ITT), and monitored total energy expenditure and physical activity energy expenditure using an accelerometer during a 12-week intervention in four groups: control, diet, exercise and diet plus exercise. RESULTS The mean body mass index was 28.0 +/- 2.7 kg/m(2) and the mean duration of diabetes was 8 +/- 6 years. Both the diet and diet plus exercise groups showed significant body weight loss compared with the control group (P < 0.05). However, the visceral fat area was reduced only in the diet and exercise group (P = 0.017) and the subcutaneous fat area was reduced only in the diet group (P = 0.009). Mean energy intake was an independent determinant of the change in subcutaneous fat area (P = 0.020) and mean total anergy expenditure was an independent determinant of visceral fat area (P = 0.002). Insulin sensitivity K(ITT) was associated with physical activity energy expenditure (P = 0.006), energy intake (P = 0.047) and the change in fructosamine level (P = 0.016) but not with changes in body weight, subcutaneous fat area, visceral fat area or adipokine level. CONCLUSIONS Exercise had an additive effect to dietary restriction on visceral fat reduction. Visceral fat area was associated with total energy expenditure, but insulin sensitivity was associated with physical activity energy expenditure.