scholarly journals 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

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

scholarly journals The efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

2019 ◽  
Author(s):  
xiao jin ◽  
Huanlin Wu ◽  
Bingxin Wu ◽  
Yukai Li ◽  
Xia Wang ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Control Group ◽  
Case Group ◽  
Soft Or ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Mixed Plaque

Abstract Background Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease. Patients and Methods This randomized controlled trial recruited 190 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included calcium coverage score (CCS), C-Reactive protein (CRP), and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months. Discussion This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.

scholarly journals The effect of maintaining high hemoglobin levels on long-term kidney function in kidney transplant recipients: a randomized controlled trial

2018 ◽  
Vol 34 (8) ◽  
pp. 1409-1416 ◽  
Author(s):  
Makoto Tsujita ◽  
Tomoki Kosugi ◽  
Norihiko Goto ◽  
Kenta Futamura ◽  
Morikuni Nishihira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Graft Function ◽  
Target Range ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Decline Rate ◽  
The Mean ◽  
Hb Concentration ◽  
The Impact

Abstract Background Posttransplant anemia may be a major determinant of chronic allograft nephropathy. However, the impact of correcting anemia on graft function remains controversial. Methods A 3-year follow-up of an open-label, multicenter, randomized controlled trial involving kidney transplantation recipients examined whether sustained maintenance of target hemoglobin (Hb) concentrations at a high level (12.5–13.5 g/dL, n = 64) with either darbepoetin alfa or epoetin beta pegol would slow the graft function decline rate as the primary efficacy endpoint, compared with maintenance of a low Hb concentration (10.5–11.5 g/dL, n = 63). Results The mean blood pressures in the two groups were well controlled throughout the study. In the high Hb group, mean Hb concentrations increased to >12 g/dL at 3 months, reaching the target range at 18 months. At the end of this study (36 months), the mean Hb concentration was 12.8 ± 0.7 g/dL in the high Hb group and 11.5 ± 1.2 g/dL in the low Hb group. The decline rate of the estimated glomerular filtration (eGFR) rate was considerably greater in the low Hb group (ΔeGFR, −5.1 ± 9.5 mL/min/1.73 m2) than in the high Hb group (−1.0 ± 8.4 mL/min/1.73 m2) (P = 0.02). Of note, only a few high Hb patients developed cardiovascular events and returned to hemodialysis, but the low Hb patients did not. Conclusion This prospective study suggests that correcting anemia to the target Hb level range (12.5–13.5 g/dL) slows renal function deterioration by >3 years in the chronic phase of allograft nephropathy.

scholarly journals The efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

2019 ◽  
Author(s):  
xiao jin ◽  
Pan Biqi ◽  
Huanlin Wu ◽  
Bingxin Wu ◽  
Yukai Li ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Control Group ◽  
Case Group ◽  
Soft Or ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Mixed Plaque

Abstract Background Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease. Patients and Methods This randomized controlled trial recruited 194 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included calcium coverage score (CCS), C-Reactive protein (CRP), and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months. Discussion This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.

scholarly journals The efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

2019 ◽  
Author(s):  
xiao jin ◽  
Huanlin Wu ◽  
Bingxin Wu ◽  
Yukai Li ◽  
Xia Wang ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Control Group ◽  
Case Group ◽  
Soft Or ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Mixed Plaque

Abstract Background Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease. Patients and Methods This randomized controlled trial recruited 194 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included calcium coverage score (CCS), C-Reactive protein (CRP), and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months. Discussion This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.

scholarly journals The efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

2019 ◽  
Author(s):  
xiao jin ◽  
Huanlin Wu ◽  
Bingxin Wu ◽  
Yukai Li ◽  
Xia Wang ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Control Group ◽  
Case Group ◽  
Soft Or ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Mixed Plaque

Abstract Background Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease. Patients and Methods This randomized controlled trial recruited 194 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included calcium coverage score (CCS), C-Reactive protein (CRP), and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months. Discussion This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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