Abstract TP416: Effects Of Pioglitazone In Patients With Abnormal Glucose Metabolism After Stroke The J-SPIRIT Study

Background and aims: The stroke patients with abnormal glucose metabolism are increasing in Japan. The J-SPIRIT study (Juntendo the Stroke Prevention study in Insulin Resistance and Impaired glucose Tolerance) was planned to investigate the effect of pioglitazone on the reduction of recurrent stroke in the patients with abnormal glucose metabolism and insulin resistance after ischemic stroke. Methods: The study is a multicenter, randomized controlled trial performed in the four hospitals in Tokyo or neighboring cities in Japan. We enrolled the patients who ; (1) were 35 to 85 years old ; (2) had symptomatic ischemic stroke; (3) had no history of diabetes and no evidence of diabetes by initial blood test. Among those patients, a standard OGTT with 75g of glucose was performed at least 2 weeks after admission. We enrolled the patients of newly diagnosed diabetes and IGT by OGTT, and randomized these patients to receive either pioglitazone or matching placebo. Results: Total 134 patients were enrolled. 58 patients were received pioglitazone, 61 were placebo control. Mean HbA1c were not different among both groups (5.6±0.38 pioglitazone vs 5.5±0.38 control) and mean observation period were 25±19.9 months in piolgitazone group and 30±16 months in control group. The data showed a trend of benefit with pioglitazone for the primary end point of recurrence of ischemic stroke compared to placebo control. (event rate=3.4% pioglitazone vs 11.6% control) Conclusions: Our data indicated pioglitazone might be able reduce the risk of recurrent stroke in the patients of ischemic stroke with newly diagnosed abnormal glucose metabolism and insulin resistance.

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Prevalence of Abnormal Glucose Metabolism and Insulin Resistance Among Subtypes of Ischemic Stroke in Japanese Patients

Stroke ◽

10.1161/strokeaha.108.522557 ◽

2009 ◽

Vol 40 (4) ◽

pp. 1289-1295 ◽

Cited By ~ 39

Author(s):

Takao Urabe ◽

Hirotaka Watada ◽

Yasuyuki Okuma ◽

Ryota Tanaka ◽

Yuji Ueno ◽

...

Keyword(s):

Insulin Resistance ◽

Ischemic Stroke ◽

Glucose Metabolism ◽

Japanese Patients ◽

Abnormal Glucose Metabolism

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The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

BMC Cardiovascular Disorders ◽

10.1186/s12872-021-01902-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hiroyuki Yamamoto ◽

Akihide Konishi ◽

Toshiro Shinke ◽

Hiromasa Otake ◽

Masaru Kuroda ◽

...

Keyword(s):

Coronary Artery Disease ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Fibrous Cap ◽

Multicenter Randomized Controlled Trial ◽

The Mean ◽

Artery Disease ◽

Fibrous Cap Thickness ◽

The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

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Effects of low glycemic index diet on insulin resistance among obese adolescent with non-alcoholic fatty liver disease: a randomized controlled trial

Medical Journal of Indonesia ◽

10.13181/mji.v28i2.2496 ◽

2019 ◽

Vol 28 (2) ◽

pp. 123-8 ◽

Cited By ~ 1

Author(s):

Agustini Utari ◽

Muhammad Saifulhaq Maududi ◽

Ninung Rose Diana Kusumawati ◽

Maria Mexitalia

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Liver Disease ◽

Nutrition Education ◽

Fatty Liver Disease ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Low Glycemic Index

BACKGROUND Obesity is strongly correlated with insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Some studies suggest that dietary intake with low glycemic index (GI) may prevent IR and reduce the incidences of NAFLD. This study was aimed to determine the effects of low GI diet on IR among obese adolescents with NAFLD. METHODS This study was a randomized controlled trial conducted in two JuniorHigh Schools in Semarang, Indonesia. The subjects were 12–14 years obese students with NAFLD, which divided into intervention and control groups according to schools using block random allocation. The intervention group received nutrition education and lunch diet (low energy, low GI, and low fat); meanwhile, the control group only received nutrition education for 12 weeks. The biochemical evaluation included fasting blood glucose (FBG) and insulin levels. IR was assessed using homeostatic model assessment-insulin resistance (HOMA-IR). RESULTS Thirty-two subjects were enrolled in this study, 16 of which were assigned to the intervention group and the other to the control group. After 12 weeks, the energy and carbohydrate intake reduced in the intervention group (p < 0.05), FBG remained unchanged, and HOMA-IR increased (4.9 [3.7]–7.2 [3.5]) compared to the control group (6.4 [4.9]–5.5 [2.8]) (p < 0.05). Meanwhile, within the control group, there were no significant differences in the energy and carbohydrate intake as well as biochemical variables. CONCLUSIONS Low GI modification diet alone may not reduce IR in the obeseadolescents with NAFLD.

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Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial

10.1101/2021.08.13.21261969 ◽

2021 ◽

Author(s):

Steven Lubitz ◽

Steven J. Atlas ◽

Jeffrey M. Ashburner ◽

Ana Lipsanopoulos ◽

Leila Borowsky ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Usual Care ◽

Controlled Trial ◽

Oral Anticoagulants ◽

Care Practice ◽

Control Group ◽

Newly Diagnosed ◽

One Year ◽

And Control

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥ 65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16,0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18,3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01,0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5,10.4). Conclusions: Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation.

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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

10.21203/rs.3.rs-16499/v2 ◽

2020 ◽

Author(s):

Jun Ni ◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

Fei Yi ◽

...

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Barthel Index ◽

Controlled Trial ◽

Survival Rates ◽

Control Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

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Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽

10.1186/s13063-021-05922-1 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Yibo Li ◽

Lili Zhu ◽

Raoying Wang ◽

Xingyue Yang ◽

Xinqi Jiang ◽

...

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Controlled Trial ◽

Control Group ◽

Health Maintenance ◽

Ocular Symptoms ◽

Thought Disorders ◽

Multicenter Randomized Controlled Trial ◽

Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

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Abstract WP419: Secondary Prevention Of Cardiovascular Events With Lifestyle Intervention In Patients With Mild Ischemic Stroke - A Randomized Controlled Trial -

Stroke ◽

10.1161/str.44.suppl_1.awp419 ◽

2013 ◽

Vol 44 (suppl_1) ◽

Author(s):

Sumio Yamada ◽

Yuji Kono ◽

Kotaro Iwatsu ◽

Hisako Okumura ◽

Junko Yamaguchi ◽

...

Keyword(s):

Ischemic Stroke ◽

Lifestyle Intervention ◽

Lifestyle Modification ◽

Controlled Trial ◽

Intervention Group ◽

Stroke Recurrence ◽

Control Group ◽

Vascular Events ◽

Randomized Controlled ◽

New Onset

Introduction: Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for the secondary prevention in patients with ischemic stroke (IS) is inadequately defined. We assessed the hypothesis that lifestyle intervention which comprised exercise, salt reduction and nutrition advice could reduce new onset of vascular events in patients with mild IS. Methods: We conducted a single-blind randomized controlled trial that enrolled 66 patients (45 men, 21 women; mean age, 63.5 yo) with acute mild ischemic stroke. The patients were randomly allocated to a lifestyle intervention group (n = 33) or control group (n = 33). We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. The primary endpoint was ospitalization due to stroke recurrence and new onset of coronary heart disease. We also evaluated blood pressure, serum lipid profile and hemoglobin A1c to compare the efficacy of the lifestyle modification intervention. Results: This trial was terminated earlier than expected because the prespecified early stopping rule for efficacy had been met. After 24 weeks intervention period, the intervention group showed a significant decrease in the clinic and home blood pressure and significant increase in the high density lipoprotein cholesterol (HDL-C) levels from the baseline to the 6-month assessment (clinic and home SBP, P <0.001; HDL-C, P =0.018), with significant differences between the randomized groups (clinic and home SBP, P <0.001; HDL-C, P =0.022). Median duration of follow-up was 2.9 years, 12 patients allocated the control group and 1 patient allocated the lifestyle intervention group had at least one major vascular event. A sequential plans analysis indicated that lifestyle intervention superior to control in interim analysis. Kaplan-Meier survival curves after log-rank test showed significant prognostic difference between randomized groups ( P =0.005). Conclusions: In conclusion, the results of this study indicate that lifestyle intervention is beneficial for preventing stroke recurrence and other vascular events.

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Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

Cerebrovascular Diseases Extra ◽

10.1159/000381417 ◽

2015 ◽

Vol 5 (1) ◽

pp. 31-40 ◽

Cited By ~ 10

Author(s):

Simone Rosa Poletto ◽

Letícia Costa Rebello ◽

Maria Júlia Monteiro Valença ◽

Daniele Rossato ◽

Andrea Garcia Almeida ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Public Hospital ◽

Controlled Trial ◽

Pilot Trial ◽

Intervention Group ◽

Total Duration ◽

Early Mobilization ◽

Functional Independence ◽

Control Group

Background: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.

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Five year follow up of a phase II study of cytotoxic immunotherapy combined with radiation in newly diagnosed prostate cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.4635 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 4635-4635 ◽

Cited By ~ 3

Author(s):

L. K. Aguilar ◽

B. Teh ◽

W. Mai ◽

J. Caillouet ◽

G. Ayala ◽

...

Keyword(s):

Prostate Cancer ◽

High Risk ◽

Controlled Trial ◽

Pathologic Complete Response ◽

Low Risk ◽

Control Group ◽

Newly Diagnosed ◽

Kinase Gene ◽

Cell Immunity

4635 Background: In the U.S. there are about 70,000 annual prostate cancer recurrences. The purpose of this study is to evaluate a product to decrease incidence of recurrence. This study is based on objective clinical responses in Phase I studies with AdV-tk (ProstAtak™, Advantagene, Inc) as monotherapy in recurrent disease and preclinical data demonstrating synergy between AdV-tk and radiation. AdV-tk is an adenoviral vector expressing the herpes thymidine kinase gene delivered to the prostate via TRUS-guided injection followed by 14 days of oral prodrug. The mechanisms of function involve direct tumor cytotoxicity, local elicitation of danger signals, recruitment and activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Method: AdV-tk was evaluated in combination with radiation in 66 newly diagnosed patients: 33 low risk (Arm A, PSA <10, Gleason <7, and T1c-T2a) and 33 intermediate-high risk (Arm B, PSA ≥10, Gleason ≥7, or T2b-T3). Arm A received two treatments with AdV-tk, immediately before and 14 days into radiation. Arm B received an additional treatment at initiation of androgen deprivation therapy. Results: Two surrogate and one definitive end-point were evaluated. Frequency of patients in Arm A with PSA nadir ≤0.2 ng/ml was 71% vs 56% in a control group of concurrent patients without AdV-tk. The two-year pathologic complete response (pCR) rate by sextant biopsy was 90% in Arm A and 94% in Arm B, compared to an expected range of 70–73%. Freedom from failure (FFF) after 60 month median follow up is 100% for Arm A and 90% for Arm B (95% for intermediate, 75% for high risk) vs best reported results of 79–90% for low risk and 48–79% for intermediate-high risk patients. The three failures in Arm B occurred within months after treatment leading to a Kaplan-Meier curve that plateaus at 90% beyond year 3. This is notably different than previous reports in which the curves continue to drop beyond year 5. Conclusion: These results suggest that AdV-tk combined with radiation therapy may significantly reduce the recurrence rate in patients with prostate cancer, particularly in patients with intermediate-high risk disease. A randomized controlled trial is warranted. [Table: see text]

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