Randomized Control Pilot Study Research Articles

Effect of 1-year oral cholecalciferol on a metabolic profile and blood pressure in poor-controlled type 2 diabetes mellitus: an open-label randomized controlled pilot study.

Hypovitaminosis D has been associated with many cardio-metabolic disorders, although their pathogenetic link still remains unclear. Our aim was to evaluate whether 1-year vitamin D (D) supplementation could improve glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition. In an open-label randomized-controlled pilot study, thirty poor-controlled (HbA1c > 59mmol/mol) type 2 diabetic patients (age 71.5 ± 3.2years, M/F 21/9, BMI 29.8 ± 3.6kg/m2) with hypovitaminosis D (25OHD 22.0 ± 11.3nmol/l) were randomized to cholecalciferol supplementation (500UI/kg p.o. weekly, + D) or observation (- D) for one year. Changes in parameters of glucose, lipid and blood pressure control at 3, 6, 9 and 12months vs. baseline were assessed. One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively. In the former, a reduction in HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR) was observed after 1year (p < 0.05 for all comparisons vs. baseline). We noticed a relationship between 1-year mean percentage changes of serum 25OHD and SBP levels (R = - 0.36, p < 0.05). One-year cholecalciferol supplementation, able to restore D status, significantly improves FG, HbA1c, SBP and HDL-cholesterol levels in patients with poor-controlled type 2 diabetes mellitus and D deficiency.

Combination treatments with therapeutic hypothermia for hypoxic‐ischemic neuroprotection

Therapeutic hypothermia is now proven to reduce death or disability in term and near-term born infants with moderate to severe hypoxic-ischemic encephalopathy. Nevertheless, many infants still survive with disability, despite treatment with hypothermia. Recent preclinical and clinical studies suggest that current protocols for therapeutic hypothermia are near-optimal. The obvious strategy, in addition to improving early initiation of therapeutic hypothermia after birth, is to combine hypothermia with other neuroprotective agents. We review evidence that the mechanisms of action of many promising agents overlap with the anti-excitotoxic, anti-apoptotic, and anti-inflammatory mechanisms of hypothermia, leading to a lack of benefit from combination treatment. Moreover, even apparently beneficial combinations have failed to translate in clinical trials. These considerations highlight the need for preclinical studies to test clinically realistic protocols of timing and duration of treatment, before committing to large randomized controlled trials.

Taking a Stand for Office-Based Workers' Mental Health: The Return of the Microbreak.

There is evidence that movement-based microbreaks can improve the cardiovascular health of desk-based employees, but their effect on mood states is yet to be investigated. As daily work tasks can potentially result in the loss of physical and psychological resources, the objective of this study was to measure the effect of movement microbreaks during formal work time on mood states. In a randomized-controlled pilot study with repeated measures (baseline, post-test, washout) of self-reported job stress and mood states (fatigue and vigor), police officers (N = 43) were exposed to movement microbreaks during work hours. A multivariate significant difference between groups was noted after the intervention period. Further analysis revealed that the experimental group reported a latent reduction in job-related stress after the 3-months washout period. Although the study was conducted with a small sample, our preliminary findings suggest that interrupting sedentary work with movement microbreaks may have beneficial effects on employee mental health. The implications of movement microbreaks for mitigating work-related stress of first responders, including police, is discussed, along with directives for future research.

Cleansing efficacy of an auto-cleaning electronic toothbrushing device: a randomized-controlled crossover pilot study

ObjectivesTo compare the cleansing efficacy of a representative “ten seconds” auto-cleaning device with that of uninstructed manual toothbrushing in a pilot study.Materials and methodsTwenty periodontally healthy probands refrained from oral hygiene for 3 days. Baseline full-mouth plaque scores (Rustogi Modified Navy Plaque Index, RMNPI) were assessed. After randomization, probands cleaned their teeth either with the auto-cleaning test device according to the manufacturer’s protocol or with a manual toothbrush. Plaque reduction was assessed by two aligned blinded investigators. After a 2-week recovery, the clinical investigation was repeated in a crossover design. The brushing pattern of the auto-cleaning device was analyzed in probands’ casts.ResultsFull-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001). The investigation of the auto-cleaning device’s brushing pattern in dental casts revealed a positive relationship of bristle rows in contact with tooth surfaces and the cleansing efficacy in the respective areas. A maximum of 2/4 bristle rows were in contact with the tooth surfaces; in some areas, the bristles had no contact to the teeth.ConclusionsUninstructed manual toothbrushing is superior to auto-cleaning. The alignment and density of the auto-cleaning device’s bristle rows need to be improved, and assorted sizes would be necessary to cover different jaw shapes.Clinical relevanceThe auto-cleaning device has been developed to accommodate individuals with poor dexterity or compliance. To date, it is unable to provide sufficient plaque reduction due to an inappropriate bristle alignment and poor fit with diverse dental arches.

P044 A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis (HOME-CF)

P044 A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis (HOME-CF)

Efficacy and Safety of Miglitol- or Repaglinide-Based Combination Therapy with Alogliptin for Drug-Naïve Patients with Type 2 Diabetes: An Open-Label, Single-Center, Parallel, Randomized Controlled Pilot Study

Combination therapy with an alpha-glucosidase inhibitor or glinide plus a dipeptidyl peptidase-4 inhibitor is thought to be effective for glycemic control because of its effects on postprandial hyperglycemia. However, no studies have directly compared these two combination therapies in relation to efficacy and safety. Eighteen patients with type 2 diabetes were studied. All had diabetes not adequately controlled with diet and exercise therapy, an HbA1c level of ≥7.5%, and were not receiving any medication for diabetes. The patients were randomized to either miglitol- or repaglinide-based combination therapy with alogliptin. Patients received miglitol or repaglinide monotherapy for 3 months (the miglitol and repaglinide groups, respectively), after which alogliptin was added to each group as combination therapy for 3 months. A meal tolerance test (MTT) was performed before the start of treatment and at the end of monotherapy and combination therapy. During the study period, decreases in HbA1c and glycated albumin were significantly greater in the repaglinide group than in the miglitol group; however, there was no significant difference between treatment groups at the end of the study. At the end of monotherapy, insulin secretion relative to glucose elevation (ISG0-30: area under the curve of insulin from 0 to 30 min during MTT [AUC0-30 of IRI]/AUC0-30 of plasma glucose) was significantly higher only in the repaglinide group; ISG0-30 did not significantly increase in either group after the addition of alogliptin. The addition of alogliptin to repaglinide monotherapy did not cause glucose-independent inappropriate insulin secretion and did not appear to increase the incidence of hypoglycemia.

Effects of subgingival air-polishing with trehalose powder on oral biofilm during periodontal maintenance therapy: a randomized-controlled pilot study

BackgroundThis pilot study was part of a larger study which compared the effect of subgingival air-polishing using trehalose powder with sonic scaling on clinical parameters during supportive periodontal therapy. Within this microbiological part of the investigation subgingival samples were taken from 10 participants to analyze the survival of different bacterial species after the two different treatments as a proof of principle.MethodsIn 10 participants two non-adjacent, single-root teeth requiring treatment (PD =5 mm with bleeding on probing (BOP) or > 5 mm) were selected following a split-mouth design and were treated either with a sonic scaler or air-polishing device and trehalose powder. For persistent pockets (PD =4 mm and BOP or > 4 mm), treatment was repeated after 3 months. Subgingival biofilm samples were taken at baseline (BL), subsequently and three and six months after treatment. After determination of the bacterial counts (TBL), isolated bacteria were identified by MALDI-TOF-MS. If unsuccessful, PCR and 16S rDNA sequencing were performed.ResultsIn both treatment groups, TBL decreased immediately after treatment remaining at a lower level. This confirms the findings of the larger study regarding clinical parameters showing a comparable effect on PD, BOP and CAL. Immediately after treatment, the diversity of detected species decreased significantly more than in the sonic group (p = 0.03). After 3 months, the proportion of Gram-positive anaerobic rods was lower in the air-polishing group (powder/ sonic 7%/ 25.9%, p = 0.025). Also, there was a greater reduction of Gram-negative aerobic rods for this group at this time (air-polishing/ sonic − 0.91 / -0.23 Log10 cfu/ ml, p = 0.020).ConclusionWithin the limitations of this study air-polishing and sonic treatment seem to have a comparable effect on the subgingival oral biofilm during supportive periodontal treatment.Trial registrationThe study was registered in an international trial register (German Clinical Trial Register number DRKS 00006296) on 10th of June 2015. HTML&TRIAL_ID = DRKS00006296.

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication.

Background. The purpose of this prospective, double-blinded randomized control pilot study was to evaluate the effect of adjunctive dexamethasone on analgesia duration and the incidence of postoperative neuropathic complication. Peripheral nerve blocks are an effective adjunct to decrease postoperative pain in foot and ankle surgery, and any possible modalities to augment their efficacy is of clinical utility. Methods. Patients were randomly assigned to a control group (n = 25) receiving nerve blocks of bupivacaine and epinephrine or an experimental group (n = 24) with an adjunctive 8 mg dexamethasone. The patients, surgeons, and anesthesiologists were all blinded to allocation. Patients had a minimum 1 year postoperative follow-up. Results. Forty-nine patients completed the protocol. There was no statistically significant difference in analgesia duration (P = .38) or postoperative neuropathic complication incidence (P = .67) between the 2 groups. Conclusions. The addition of dexamethasone to popliteal nerve blocks does not appear to affect analgesia duration or incidence of postoperative neuropathic complications. However, our study was underpowered, and we recommend a larger scale prospective study for validation.Levels of Evidence: Level II: Prospective, randomized control pilot study.

Evaluating the Effectiveness of Online Educational Modules and Interactive Workshops in Alleviating Symptoms of Mild to Moderate Depression: A Pilot Trial.

IntroductionDepression is a common health concern in primary care with barriers to treatment well documented in the literature. Innovative online psychoeducational approaches to address barriers to care have been well received and can be cost effective. This pilot trial evaluated the effectiveness of an online psychoeducation curriculum intended to alleviate symptoms of depression while utilizing minimal staff resources.MethodsA small (n = 29) randomized control pilot study was conducted. Online psychoeducational content was delivered in 5 to 10-minute videos over 8 weeks. Participants engaged in moderated discussions on workshop topics. The Patient Health Care Questionnaire (PHQ-9) was used to measure pre/post scores. Two Likert scale questions were used to determine subjective changes in understanding of depression and coping skills.ResultsPaired T-test analysis showed an average PHQ-9 improvement of 4.37 (P = .01) in the intervention arm and 1.81 (P = .172) in the control group. No significant difference in delta PHQ-9 score was found between groups via difference in difference analysis (P = .185). Effect size was 0.59. No improvement in Likert scores for question 1 or 2 were detected by paired T test in either group.ConclusionThis pilot trial of interactive online psychoeducational content shows initial promise as there was a significant improvement in PHQ-9 scores within the intervention arm. The comparison of delta scores between intervention and control arms was not statistically significant although this is likely due to the underpowered nature of the pilot trial. This data trend justifies the need for a larger validation trial of this intervention.

Implementation of Dialogical Sequence Analysis as a Case Formulation for the Assessment of Patients at a Community Mental Health Centre : Randomized Controlled Pilot Study

Background: We implemented a case formulation method, which is based on dialogical sequence analysis (DSA) in a community mental health center. The aim was to achieve better congruence and collaboration between the patient and professionals concerning the tasks and goals of the assessments. Here we report a randomized clinical study in which we compare DSA-based and standard psychiatric assessments. Methods: In this randomised clinical study, we compared DSA-based and standard psychiatric assessments. There were 40 outpatients in both, the DSA and the assessment as usual (AAU) groups. We recorded the lengths of individual assessment periods, the number and durations of visits, and the numbers of clinicians who were involved in the various phases of assessment. The Working Alliance Inventory was completed by the patients (WAI-P) and the clinicians (WAI-T) during the treatment planning (i.e. final) visit. Results: In our results, the total WAI-P and WAI-T scores and all WAI subscale scores correlated significantly in the DSA group (Spearman’s rho = 0.562–.667, p &lt; 0.01). In the AAU group, the only significant – albeit weaker – correlation was found in the WAI Bond subscale (rho = 0.369, p &lt; 0.05). Compared to the AAU group, assessment periods were shorter and the number of visits were fewer in the DSA group. Conclusion: Our findings are clinically notable. They show that the patient-centred, DSA-based case formulation complements psychiatric assessment in a collaborative way and results in a better joint understanding regarding the patient’s problems and needs in a shorter time period than the standard assessment.

Effect of Helicobacter pylori-eradication therapy on hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomized-controlled pilot study.

Background Helicobacter pylori infection has been associated with insulin resistance and non-alcoholic fatty liver disease (NAFLD). This study was done to evaluate the effect of H. pylori-eradication therapy (HPET) in patients with NAFLD compared to standard management therapy (SMT).MethodsEighty NAFLD patients with H. pylori co-infection were randomized into SMT (diet and exercise, n = 36) and HPET (SMT plus amoxicillin, clarithromycin, and pantoprazole, n = 44) groups. The controlled attenuation parameter (CAP), anthropometric parameters, liver enzymes, lipid profile, and glycemic parameters including homeostasis model assessment-insulin resistance (HOMA-IR) were measured and compared between two groups at the baseline and 24 weeks.ResultsSixty-four participants (SMT group [n = 28] and HPET group [n = 36]) were included in a modified intention-to-treat analysis. Both the SMT group and the HPET group had a significant reduction in CAP scores at 24 weeks (P = 0.002 and P < 0.001, respectively), but the change between the groups was insignificant (P = 0.213). Successful eradication of H. pylori occurred in 68% of the HPET group and led to greater improvement in HOMA-IR at 24 weeks compared to SMT or non-responder patients (P = 0.007). The liver enzymes reduced significantly at 24 weeks in both groups, but the changes between the groups were similar. The lipid parameters remained unchanged within the groups and between the groups at 24 weeks. A significant increase in the levels of reduced glutathione was noted in the HPET group, but the change between the two groups was not statistically different.ConclusionsHPET was found to be comparable to SMT alone in reducing hepatic steatosis and liver enzymes at 24 weeks in NAFLD patients. However, successful eradication of H. pylori led to greater improvement in HOMA-IR (Trial registration CTRI/2017/05/008608).

A novel rat model for tracheal mucosal damage assessment of following long term intubation

ObjectiveTracheal mucosal damage is a well-known complication of endo-tracheal intubation and animal models are essential for studying the underlying cellular injury cascade. The novel rat model described here is based on retrograde intubation via tracheotomy and suture fixation of the tube. It aims to simulate the common clinical scenario of tube-related airway damage due to long term intubation. Study designProspective randomized control pilot study. MethodsMale Sprague-Dawley were randomly assigned into two groups: control (no intubation, n = 10), one week of intubation (n = 13). The animals were then euthanized and the trachea was sent for histological analysis. Epithelial damage, mucosal thickness, mucosal gland hypertrophy and fibrosis were reviewed. ResultsIntubation procedure survival rate was 84.6% (11/13) and 100% in the control (10/10). The damaged ciliary mechanism was a common finding in the intubated group compared to the preserved normal ciliary architecture in almost all control rats. Average tracheal mucosal thickness was 119.0 ± 21.8 μm for the control group and 254.6 ± 22.8 μm for the intubated group, (p < 0.001). The ciliary damage score was 1.00 ± 0.02 in the intubated group, and 0 ± 0.02 in the control group. (p < 0.001). The (objective) average total tracheal mucosal gland area was 19,530 ± 24,606 in the intubated group and 10,031 ± 23,461 in the control group (p < 0,05). Collagen deposition seems higher in the intubated trachea compared to the control. ConclusionsWe describe a novel rat-based animal model for simulating tracheal mucosal damage following long term intubation. This animal model is easy to carry out, reproducible and involves containable animal mortality rates. Level of evidenceI.

A Randomized-Controlled Trial Pilot Study Examining the Effect of Pelvic Floor Muscle Training on the Irisin Concentration in Overweight or Obese Elderly Women with Stress Urinary Incontinence.

Objective This study aimed to examine the effect of pelvic floor muscle training on the irisin (Ir) concentration in overweight or obese elderly women with stress urinary incontinence. Methods The number of participants included in analysis was 49: 28 women in the experimental group and 21 women in the control group. The experimental group (EG) underwent pelvic floor muscle training, whereas no therapeutic intervention was applied to the control group (CG). Irisin concentration, severity of urinary incontinence (RUIS), and body mass index (BMI) were measured in all women at the initial and final assessments. Results By comparing the initial and final assessment results we have been able to demonstrate statistically significant differences in the measured variables in the experimental group. No statistically significant differences in the measured variables were reported for the control group at the initial and final assessments. Moderate negative correlation was observed between the BMI results with the irisin concentration results in the EG at the initial assessment and no correlation at the final assessment. Weak positive correlation was observed between the BMI results with the irisin concentration in the CG at the initial and final assessment. Conclusion Further studies are necessary to observe the regulation of irisin concentration and explain mechanisms underlying these effects.

Dose Matters: A Smartphone Application to Improve Asthma Control Among Patients at an Urban Pediatric Primary Care Clinic.

Objective: As the most common chronic condition of childhood, asthma is a frequent target for family education. However, current educational strategies rarely tailor to learning style or literacy level. Thus, we developed and implemented a smartphone application (app) leveraging gamified features entitled CHANGE Asthma ("Clinic, Home, And on the Go Education for Asthma"). We subsequently assessed its impact on asthma control. Methods: Patients aged 4-11 years with a previously documented childhood asthma control test (C-ACT) score of <20, indicating poor control, were recruited to participate in this randomized control pilot study. The intervention group downloaded CHANGE Asthma; asthma control was assessed at enrollment and at follow-up. The changes in C-ACT score in both groups were compared using analysis of covariance (primary outcome). App usage was monitored for 4 months following download, and the relationship between usage time, and the change in C-ACT score was assessed via linear regression. Results: The control and intervention groups both included 20 caregivers with 75% of participants completing follow-up. Although C-ACT scores among intervention participants significantly improved at follow-up, compared to their own baseline (P = 0.04), the change of C-ACT score did not significantly differ from that of the control group (P = 0.78). Among the intervention participants, there was a positive, dose-dependent relationship between app usage time and positive change in C-ACT score (P = 0.03). Conclusion: Usage of a gamified app was associated with a dose-dependent improvement in asthma control over time, suggesting that further evaluation of apps for asthma education, and perhaps for other chronic conditions, is warranted.

Post–nail procedure analgesia: A randomized control pilot study

Post–nail procedure analgesia: A randomized control pilot study

MHealth Improved Fruit and Vegetable Accessibility and Intake in Young Children

ObjectiveTo explore the potential of mHealth using smartphones to improve fruit and vegetable intake in children. DesignA 10-week randomized control and intervention pilot study. SettingStory time sessions at local libraries. ParticipantsA convenience sample of 30 parents and children (aged 3–8 years). InterventionDelivery of nutrition intervention through the mobile Jump2Health website, Facebook posts, and text messages. Main Outcome MeasuresElectronic food photos of children's meals and snacks, 10-question survey related to fruit and vegetable consumption, reflectance spectroscopy via Veggie Meter to measure skin carotenoid levels, body mass index percentiles, and a mobile learning survey. AnalysisDescriptive statistics and Wilcoxon matched-pairs signed-rank test. ResultsVeggie Meter values for children and parents showed significant week × treatment interactions in the intervention group compared with the control group for both children (P < .001 and parents (P < .001). Conclusions and ImplicationsThis pilot study offers a potentially effective program including a mobile Web site, social media, and test message components to increase fruit and vegetable intake of young children.

Is A Combination of Antibiotics and Non-Steroidal Anti-Inflammatory Drugs More Beneficial Than Antibiotic Monotherapy For The Treatment of Female Acute Uncomplicated Cystitis? A Randomized Controlled Pilot Study.

Purpose: To compare the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) combination therapy to single-agent antibiotic therapy for the resolution of symptoms during two restricted activity days in patients with acute uncomplicated cystitis (AUC)Materials and Methods: We performed a prospective, randomized control pilot study. A total of 55 patients were enrolled. Group I (n=28) was treated with cepodoxime (100 mg twice per day), and Group II (n=27) was treated with cepodoxime (100 mg) and aceclofenac (100 mg) twice per day; both groups were treated for three days. Upon dysuria after each administration, the participants entered a value on a numerical pain scale. The primary outcome was whether there were any differences in the decrease rate in pain scale between the two groups.Result: The average age of the 55 patients was 49.9 ± 13.5 years, and prior to the clinical visit, the patients ex-perienced an average of 2.4 ± 2.2 days of dysuria symptoms. The average numerical pain scale score for dysuria was 4.98 ± 2.18. Thirty-four patients (61.8%) showed positive culture results, and E. coli was the most commonly found bacteria, cultured in 32 patients.Fifty-one patients visited the clinic on day 7, and 42 (76.4%) reported symptom improvement, while nine patients (16.3%) had persistent symptoms. The follow-up numerical pain score was 0.39 ± 1.02 points. The pain score was dramatically decreased after medication. No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134). However, group II showed faster symptom resolution (P = 0.035) at the third administration (day 1.5).Conclusion: Combination therapy with NSAIDs and antibiotics for AUC patients can improve symptoms faster during two restricted activity days when patients have difficulty performing daily living activities.

A novel rat model for assessment of laryngotracheal injury following transoral intubation

ObjectiveLaryngotracheal damage is a well-described complication of endotracheal intubation and animal models are essential for studying the underlying cellular injury cascade. This novel rat model is based on transoral intubation and aims to simulate the common clinical scenario of tube-related airway damage. MethodsProspective randomized control pilot study. 28 male Sprague-Dawley were randomly assigned into three groups: control, 3-h' intubation and 6-h' intubation. The animals were then euthanized and their laryngotracheal complexes sent for histological analysis. Epithelial damage, mucosal thickness and mucosal gland hypertrophy were reviewed. ResultsTotal of 13 control animals and 15 intubated animals. 10 intubated animals survived the study protocol. Loss of epithelial surface architecture including damage to the microscopic ciliary mechanism was a common feature amongst all intubated animals. Average mucosal thickness of the larynx (including vocal cords and subglottic area) was 143 ± 88 μm for control rats, 315 ± 101 μm for rats intubated 3 h and 574 ± 174 μm for rats intubated 6 h .This was a statistically significant difference. Average mucosal gland hypertrophy in the laryngeal subsite was 0.41 ± 0.5 in control rats, 1.4 ± 0.5 in rats intubated 3 h and 2.0 ± 0.0 for rats intubated 6 h (statistically significant difference). There was a clear difference between three and 6 h of intubation with poorer mucosal injury parameters for longer intubation. ConclusionsWe describe a novel rat-based animal model for simulating airway mucosal damage following transoral intubation. This animal model is easy to carry out, reproducible and involves containable animal mortality rates.

Effect of highly concentrated hyaluronic acid/chondroitin sulphate instillation on ureteric stent-induced discomfort after ureteroscopic lithotripsy: a multicentre randomised controlled pilot study.

To investigate the effectiveness and safety of instilling highly concentrated hyaluronic acid (HA)/chondroitin sulphate (CS) on ureteric stent-related pain, urinary symptoms, and quality of life (QoL) of patients who underwent ureteroscopic lithotripsy for ureteric stones followed by ureteric stent placement. Eligible patients were randomly allocated to receive intravesical instillation with HA/CS or normal saline just after ureteric stent placement. Just before stent removal on postoperative day 7, the patients completed the Ureteric Stent Symptom Questionnaire (USSQ), International Prostate Symptom Score (IPSS) QoL question, and a pain visual analogue scale (VAS). In total, 92 patients (46 each in the treatment and control arms) completed the study. The groups did not differ in terms of age or stent indwelling time. Compared with the control group, the treatment group had significantly lower USSQ urinary symptom domain scores (24.6 vs 32.5; P < 0.001), better IPSS QoL scores (3.5 vs 4.4, P = 0.018), and lower VAS pain scores (2.0 vs 3.2; P < 0.001). They also had lower total body pain subscores (16.7 vs 22.0; P = 0.01) and lower additional pain subscores due to urinary tract infections (2.1 vs. 3.2; P = 0.01) in the USSQ. Highly concentrated HA/CS effectively improved urinary symptoms and pain, and reduced the need for additionalmedication or procedures after ureteric stent placement.

Dulaglutide-Combined Conventional Insulin Therapy Contributes to Ideal Glycemic Control in Noncritically Ill Hospitalized Patients

Object: We investigated whether dulaglutide (DU)-combined conventional insulin therapy is beneficial for glycemic control in noncritically ill hospitalized patients with type-2 diabetes. Method: This study was a prospective, randomized-controlled pilot study. Participants were randomized to either basal-plus (BP) therapy, those receiving basal insulin and corrective doses of regular insulin before meals, or BP+DU therapy, those receiving BP therapy combined with DU. Blood glucose (BG) levels before and after every meal were measured for 7 days after assignment. Because we consider the ideal BG during hospitalization to be within 100-180 mg/dL, we define this range as the hospitalized ideal glucose range (hIGR). We compared the percentage of hIGR with all measured BGs (%hIGR), mean BG, glucose variability (GV), and insulin dose. Result: Of 54 patients participating in the study, 27 were assigned to the BP group and 27 to the BP+DU group. The %hIGR was significantly higher and percentage of BG &amp;gt;240 and BG &amp;lt;70 was significantly lower in the BP+DU compared with the BP group. The mean BG, SD, coefficient of variation, and total regular insulin dose in the BP+DU group were significantly lower than those in the BP group (Table). No significant side effects were observed.BP groupBP+DU groupn=974, N=27n=899, N=27P valueBaseline characteristicsAge, years70.1±1470.9±130.822Male, N (%)18 (67)15 (56)0.577BMI, kg/m224.6±5.725.1±6.70.904Duration, years10.1±8.88.7±9.40.488HbA1c, %8.0±1.98.2±1.70.401Frequency of the measured BGs in each BG ranges, n (%)BG &amp;lt;7021 (2.3)4 (0.4)&amp;lt;0.001BG 71–9963 (7)99 (10)0.019BG 100–180 (%hIGR)399 (44)545 (56)&amp;lt;0.001BG 181–240232 (26)244 (25)0.748BG &amp;gt;240184 (21)82 (8)&amp;lt;0.001Daily BG profiles, mean±SD mg/dLFasting131±38127±400.254After breakfast244±61196±540.004Before lunch216±65173±56&amp;lt;0.001After lunch195±62182±540.041Before dinner135±47143±440.232After dinner203±62177±54&amp;lt;0.001mean BG after first day183±29162±300.014Glucose variability, mean±SDIndividual glucose SD during study62.5±2145.0±140.001Individual glucose CV during study0.34±0.090.27±0.050.002Hypoglycemic event, N (%)Patients &amp;lt;70 mg/dL9 (33)3 (11)0.099Insulin therapy, mean±SD U/dayTotal insulin17.1±6.616.1±6.40.762Total glargine insulin12.0±5.712.6±4.80.55Total regular insulin5.4±2.53.6±2.80.017n, number of the measured BGs; N, number of the patients Conclusion: BP+DU therapy reduced the frequency of hyperglycemia and hypoglycemia and resulted in a lower GV. Disclosure N. Fushimi: None. T. Shibuya: None. Y. Yoshida: None. S. Ito: None. H. Hachiya: None. A. Mori: None.