title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Intervention | chronic pain, pain | CHRONIC PAIN | A novel application of VR for chronic pain management (Reducept) was used with an Oculus Go (Facebook Technologies, LLC) head-mounted display. This therapeutic application, still investigational, was designed in cocreation with patients, psychologists, educationalists, and software developers. It is based on the biopsy... | PMC10205123 |
Study Procedures | pain | ADVERSE EVENTS | The treating physician (J.W.K.; anaesthesiologist and pain physician) identified eligible patients, provided verbal and written information, and subsequently obtained written informed consent. Patients were randomly assigned (1:1) to the VR or control group using computer-generated block randomization. Randomization wa... | PMC10205123 |
Outcome Measures | CHRONIC PAIN | Outcome measures were chosen according to the core outcome measures for chronic pain as recommended in the IMMPACT guidelines. | PMC10205123 | |
Primary Outcome | The primary outcome was quality of life measured by the short form-12 (SF-12) at 4 weeks. | PMC10205123 | ||
Secondary Outcomes | Pain, pain | Secondary outcomes were SF-12 at 4 months, daily pain scores and analgesics use, and the questionnaires at 4 weeks and 4 months as described. Another outcome was feasibility in terms of acceptability, usability, and tolerability.Pain scores comprised pain scores (0 to 100 mm) on “worst pain experienced today” and “leas... | PMC10205123 | |
Feasibility | ADVERSE EVENT | Discontinuation of VR was registered as an acceptability outcome, together with reasons for withdrawal. Adherence was monitored through weekly telephone interviews. Adverse events were registered as a tolerability outcome through open-ended questions during the weekly telephone calls. | PMC10205123 | |
Statistical Analyses | Pain | ADVERSE EVENTS, SECONDARY | All analyses were done using IBM SPSS Statistics 25. Outcomes were analyzed following the intention-to-treat principle. Descriptive statistics were used for presenting baseline data, adverse events, and feasibility outcomes.For primary efficacy analyses, linear mixed models were used to analyze the effectiveness of the... | PMC10205123 |
RESULTS | pain | SECONDARY | A total of 207 patients were assessed for eligibility and 41 patients were included between January 2020 and January 2021 (Fig. Study flowchart. TENS indicates transcutaneous electrical nerve stimulation.Patient CharacteristicsISCED 0-1: early childhood to primary education.ISCED 2: lower secondary.ISCED 3-4: upper sec... | PMC10205123 |
Primary Outcome | Physical and mental scores of the SF-12 are shown in Figure SF-12 physical (A) and mental (B) scores, mean and SD. SF-12 indicates short form-12.EMMs (95% CIs) of SF-12 Physical and SF-12 Mental at 4 Weeks and 4 MonthsEMM indicates estimated marginal mean; SF-12, short form-12; VR, virtual reality.No significant main t... | PMC10205123 | ||
Secondary Outcomes | pain | A significant main treatment effect of VR was seen on the daily worst experienced pain score (Mean and standard error of the mean of daily worst VAS pain score (A) and daily least VAS pain score (B) during the intervention period. In the intervention group, data were missing for 1 patient from day 8, for 1 patient from... | PMC10205123 | |
Feasibility | dizziness | ADVERSE EVENTS | Three out of 20 (15%) patients in the VR group reported mild and temporary symptoms of dizziness. No patients discontinued the intervention because of adverse events. During the weekly telephone calls, 1 patient reported not being motivated to adhere to the study protocol, 3 patients reported to have missed 2 out of 7 ... | PMC10205123 |
DISCUSSION | PMC10205123 | |||
Main Findings | opioid dependence, low back pain, anxiety, chronic pain, pain, depression, disability, coronavirus disease 2019 | CHRONIC PAIN, COMPLEX REGIONAL PAIN SYNDROME, CORONAVIRUS DISEASE 2019, COMPLICATIONS | We did not find an effect of 4 weeks of VR behavioral therapy-based pain management and education intervention on the physical and mental function of patients with nonspecific CLBP referred to a pain clinic. VR seemed to positively affect daily worst and least experienced pain. Opioid use in the VR group was halved. VR... | PMC10205123 |
Strengths and Limitations | chronic pain, pain | CHRONIC PAIN | This study has several strengths and limitations. This practice-based study was conducted in accordance with the IMMPACT guidelines, which are strongly recommended for chronic pain research.When compared with standard CBT, the total amount of VR treatment of <5 hours in 4 weeks is rather low. Behavioral therapy is give... | PMC10205123 |
Clinical Implications and Recommendations | chronic pain, pain | CHRONIC PAIN, MINOR, ADVERSE EFFECTS | A CBT-based VR intervention might offer a valuable contribution to the multidisciplinary biopsychosocial treatment of CLBP and possibly other chronic pain conditions. This study illustrates that VR pain treatment can be brought close to the patient’s personal environment allowing them to access the treatment at a time ... | PMC10205123 |
CONCLUSION | pain | We conclude that 4 weeks of a novel self-administered behavioral therapy-based VR program for CLBP does not seem to improve quality of life, but is well tolerated and may positively affect daily pain experience. | PMC10205123 | |
Supplementary Material | PMC10205123 | |||
ACKNOWLEDGMENTS | The authors thank Petra Koopmans, PhD, Radboud University Medical Center, Department of Health Evidence, Section Biostatistics, biostatistician, for her support and review of the statistical analyses.The trial was registered at ClinicalTrials.gov (NCT04042090).This work was supported by the European Regional Developmen... | PMC10205123 | ||
REFERENCES | PMC10205123 | |||
Keywords | HEART | Spinal anesthesia induces sympatholysis and is usually combined with dexmedetomidine or propofol which induce different hemodynamic changes. The purpose of this study was to compare the effect on autonomic nervous system between dexmedetomidine and propofol combined with spinal anesthesia. Patients aged 20–65 undergoin... | PMC10651711 | |
Introduction | bradycardia, hypotension | Spinal anesthesia causes iatrogenic central sympatholysis by blocking the pre-ganglionic sympathetic fibers and cardiac sympathetic innervation. This iatrogenic sympathetic blockage causes hypotension and bradycardia, which occasionally require clinical intervention [In clinical practice, spinal anesthesia is usually c... | PMC10651711 | |
Materials and methods | This study was approved by the Ajou Institutional Review Board on October 29, 2019 (AJIRB-MED-INT-19-350) and the Clinical Trial registration was done prior to the enrollment of the first patient ( | PMC10651711 | ||
Measurement of HRV | STARE, PHYSICAL STRESS | HRV was measured using an SA-3000P (Medicore Co., Ltd. Hanam, Gyeonggi-Do, Korea). Baseline HRV was measured on the morning of the day before surgery in a quiet room in the ward. The patient rested for 5 min before the measurement, and electrocardiogram (EKG) leads were applied. During the measurement, conversation was... | PMC10651711 | |
Anesthesia | bradycardia, hypotension | Patients entered the operating room with no premedication. Standard monitoring of pulse oximetry, EKG, noninvasive blood pressure (BP), and bispectral index (BIS, Medtronic, Minneapolis, MN, USA) was performed. After measuring baseline hemodynamics, 5 L/min of oxygen was administered using a facial mask. The patient wa... | PMC10651711 | |
Statistical analysis | All statistical analyses were performed using SPSS (version 26.0; IBM Corp., Armonk, NY, USA). For continuous data, normality was assessed using the Shapiro–Wilk test, and the independent | PMC10651711 | ||
Results | PMC10651711 | |||
Demography | Sixty patients completed the study (Fig.
Flow diagram
Patient characteristics and intraoperative dataValues are mean ± standard deviation and number (%)D group, dexmedetomidine group; P group, propofol group | PMC10651711 | ||
High baseline LF/HF ratio vs. low baseline LF/HF ratio | hypotension | A previous study reported that an preoperative LF/HF ratio > 2.3 was correlated with post-spinal anesthesia hypotension [ | PMC10651711 | |
All patients | Of the 59 patients, 45 were in the low LF/HF ratio group and 14 were in the high LF/HF ratio group. Vasoactive drugs were required in 10 patients (22.2%) in the low LF/HF ratio group and in five patients (35.7%) in the high LF/HF ratio group, and it was not statistically significant (P = 0.483). The hemodynamic data sh... | PMC10651711 | ||
Dexmedetomidine group | Of the patients in the dexmedetomidine group, six were in the high LF/HF ratio group and 24 were in the low LF/HF group. Vasoactive drugs were required in two patients (33.3%) in the high LF/HF ratio group and in six patients (25.0%) in the low LF/HF ratio group. However, this difference was not statistically significa... | PMC10651711 | ||
Propofol group | Of the patients in the propofol group, eight were assigned to the high LF/HF ratio group and 21 to the low LF/HF ratio group. Vasoactive drugs were required in three patients (37.5%) in the high LF/HF ratio group and in four patients (19.0%) in the low LF/HF ratio group. Although the difference was not statistically si... | PMC10651711 | ||
Discussion | Bradycardia, bradycardia, iatrogenic sympathetic block, hypotension, hypotensive | HYPOTENSIVE | This randomized controlled trial showed that HRV dynamics changed through spinal anesthesia and sedation, however, dexmedetomidine and propofol exhibited similar trends in HRV dynamics. Although dexmedetomidine and propofol did not result any significant difference in the HRV dynamic, the difference in hemodynamic chan... | PMC10651711 |
Authors’ contributions | IKY conceptualized the study. HBJ, YJC, and SHS performed data curation. HBJ, YJC, and IKY investigated references. YJC devised the research methodology. SHS performed visualization of the results. HBJ wrote original draft and IKY reviewed and edited. All authors reviewed the manuscript. | PMC10651711 | ||
Funding | None. | PMC10651711 | ||
Declarations | PMC10651711 | |||
Ethics approval and consent to participate | This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ajou Institutional Review Board on October 29, 2019 (AJIRB-MED-INT-19-350). | PMC10651711 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10651711 | ||
Competing interests | The authors have no relevant financial or non-financial interests to disclose. | PMC10651711 | ||
References | PMC10651711 | |||
Keywords | Acne vulgaris | ACNE VULGARIS | Acne vulgaris is challenging to treat for several individuals. Laser therapy may be a desirable alternative to traditional therapies with limited success. This study aimed to assess efficacy of fractional COOpen access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with... | PMC10435603 |
Introduction | Acne vulgaris, acne | SCARRING, ACNE VULGARIS, ACNE, ACNE VULGARIS | Acne vulgaris is one of the main reasons for dermatological consultation with substantial physical and psychosocial burden [Numerous laser devices were proven successful in acne therapy, as they provide an efficient treatment of acne with a short recovery period and fewer drawbacks, notably the Nd:YAG laser, which has ... | PMC10435603 |
Material and methods | nodulocystic acne, hypertrophic scars, keloids, malignancy, infection, comedonal acne, acne, Acne, dermatitis | SYSTEMIC DISEASE, NODULOCYSTIC ACNE, HERPES INFECTION, INFECTION, ACNE, ACNE, DERMATITIS, PHOTOSENSITIVITY | This prospective randomized split-face comparative study was conducted with 30 patients with acne vulgaris. Patients were selected from the attendants of the Dermatology Outpatient Clinic of Al Zahraa University Hospital, Cairo, Egypt.The study was performed over a period from July 2021 to September 2022. The study was... | PMC10435603 |
Treatment sessions | INFLAMMATION | Each patient received four laser treatment sessions at 14 days of interval: Nd:YAG laser on half of the face and fractional COBefore the session, the face was washed with water, and an anesthetic cream (Pridocaine cream®; lidocaine 2.5% and prilocaine 2.5%) was left for 40 min. After removing it, skin was cleansed with... | PMC10435603 | |
Efficacy assessments | Erythema, hyperpigmentation, Acne lesions, Pain, hypopigmentation, erythema, pain, acne lesions, acne, Acne | ERYTHEMA, SCAR, HYPERPIGMENTATION, HYPOPIGMENTATION, ERYTHEMA, ADVERSE EFFECTS, ACNE, ACNE, SCARRING | Primary assessment was done by count of acne lesions at 1 month after the last session [Secondary assessment was performed through severity grading by the Global Acne Severity Scale (GEA Scale), acne lesions improvement percentage, and patient’s satisfaction [Clinical images were taken by an iPhone 6 s Plus (12 mega pi... | PMC10435603 |
Statistical analysis | Data were managed through the Statistical Package for Social Science (IBM SPSS) version 23. The comparison between two modalities of treatment with qualitative data was done by using Chi-square test. The comparison between two modalities of treatment with quantitative data and non-parametric distribution was created by... | PMC10435603 | ||
Discussion | sebaceous gland damage, tumor necrosis, shock, edema, erythema, acne scars, comedonal lesions, acne, comedonal acne lesion, AV lesions | ADVERSE EFFECTS, TUMOR NECROSIS, SHOCK, EDEMA, ERYTHEMA, ACNE, HEAT | Efficacy of Nd:YAG laser to treat acne has been established in multiple studies [The current study demonstrated improvement of AV lesions by both Nd:YAG laser and fractional COOn Nd:YAG side, inflammatory and comedonal acne lesion numbers decreased by 81.41% and 61.70%, respectively, from baseline to a month after the ... | PMC10435603 |
Conclusion | acne | ACNE | Fractional CO2 and Nd:YAG 1064-nm lasers are safe, tolerable, and highly effective therapeutic options for acne. However, fractional CO2 laser had a higher percent of improvement and patient’s satisfaction compared with long pulsed Nd:YAG. To our knowledge, this seems to be the first comparison between fractional CO2 l... | PMC10435603 |
Limitations | The small number of participants ( | PMC10435603 | ||
Acknowledgements | This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. | PMC10435603 | ||
Author contribution | Mervat Hamdino: contributed to the design and conception, and performed the procedures and revision of the manuscript.Tasneem Muhammad Hammoda: contributed in acquisition of data, analysis and interpretation of data, and drafting of the manuscript.Naglaa Abdallah Ahmed: contributed to the conception and revision of the... | PMC10435603 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10435603 | ||
Data Availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10435603 | ||
Declarations | PMC10435603 | |||
Ethical approval | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and with the 1964 Helsinki declaration. The study was approved by the Research Ethics Committee of Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt with approval code (2021... | PMC10435603 | ||
Conflict of interest | The authors declare no competing interests. | PMC10435603 | ||
Informed consent | All study participants provided written informed consent to the study. | PMC10435603 | ||
References | PMC10435603 | |||
1. Introduction | Obesity, intestinal behavior, weight gain, satiety, overweight, adiposity, intestinal dysbiosis, weight loss | OBESITY, DISEASE, ADIPOSITY | These authors contributed equally to this work.Background: Sorghum is a cereal source of energy, carbohydrates, resistant starch, proanthocyanidins, and 3-deoxyanthocyanins; it promotes satiety by slowing digestion and benefits intestinal health. Objective: This study investigated the effects of extruded sorghum SC319 ... | PMC10490362 |
2. Materials and Methods | PMC10490362 | |||
2.1. Raw Materials and Processing | ± | SCHENCK | Whole-grain sorghum (SC319 genotype) was grown in Nova Porteirinha, MG, Brazil, by Embrapa Milho e Sorgo. The grains were harvested in September 2013. They were milled into flour using a disc mill (Perten Instruments, Huddinge, Sweden) at position 2. The sorghum flour was combined with 10% fine granulated sugar (sucros... | PMC10490362 |
2.2. Trial Design | overweight | This was an 8-week, single-blind, controlled, randomized nutritional intervention study conducted in men with overweight. This study was conducted using data from the second phase of a crossover study previously conducted by our research group [The study was approved by the Human Research Ethics Committee of the Federa... | PMC10490362 | |
2.3. Participants | obesity, overweight | OBESITY, DISEASES | Volunteers were recruited in Viçosa-MG, Brazil, through advertisements on social networks, pamphlets, and posters. An email address and a telephone number were made available to individuals who were interested in participating in the study. In the first contact, the objectives and conditions of the study were informed ... | PMC10490362 |
2.4. Interventions and Test Meals | Volunteers attended the laboratory daily to consume the test preparations (breakfast cereal with milk or dairy product, or a drink) at breakfast and guided to follow a 500 kcal/day caloric restriction diet. On the weekends, the volunteers consumed the meals at home. The volunteers were instructed to consume the entire ... | PMC10490362 | ||
2.5. Outcomes | tumor necrosis | TUMOR NECROSIS | The primary outcome of this study was the effect on anthropometric measurements such as body weight, waist circumference, sagittal abdominal diameter, waist-to-height ratio, and body fat percentage. The second outcome was the effect of the interventions on intestinal health, including short-chain fatty acid synthesis, ... | PMC10490362 |
2.6. Randomization, Allocation, and Sample Power | Participants were randomized using a random sequence, according to the corresponding numbers received prior to the intervention, using a Microsoft Excel 365 software spreadsheet for distribution between groups. Allocation concealment occurred so that investigators or research participants did not know whether the next ... | PMC10490362 | ||
2.7. Assessment of Anthropometry and Body Composition Markers | overweight [ | Anthropometric and body composition evaluations were performed by a single trained researcher. Body weight was assessed using an electronic platform scale (Model 2096 PP, Toledo, Brazil), with a capacity of 150 kg and precision of 50 g. Height was measured using a stadiometer (AlturexataBody composition was assessed by... | PMC10490362 | |
2.8. Inflammatory Markers | tumor necrosis | TUMOR NECROSIS | All participants underwent overnight fasting, and blood samples were collected at baseline and endpoint. Enzyme-linked immunosorbent assay (ELISA) was utilized to analyze the levels of inflammatory markers, including interleukin 6, interleukin 10, and tumor necrosis factor-α. The Milliplex Map Human Cytokine/Chemokine ... | PMC10490362 |
2.9. Fecal Samples | At baseline and endpoint (8 weeks after) of the intervention, study participants were instructed to provide a fecal sample as close to the collection time as possible. If immediate processing was not feasible, the samples were refrigerated at 4 °C for a maximum of 12 h. Participants transported the fecal samples to the... | PMC10490362 | ||
2.10. Fecal pH | The fecal pH level was assessed using a digital pH meter T-1000 (Tekna, São Paulo, Brazil). To perform the measurement, one gram of feces was transferred into a 15 mL falcon-type tube, and then 10 mL of ultrapure water was introduced. The mixture was thoroughly homogenized by vortexing, and the pH reading was obtained ... | PMC10490362 | ||
2.11. Organic Acid Analysis | To extract and identify organic acids from fecal samples, 500 mg of feces was weighed in duplicate and stored at −80 °C until further analysis. The frozen feces were thawed at room temperature (23 ± 2 °C) and homogenized with 1 mL of ultrapure water. Subsequently, the samples underwent centrifugation at 12,000× | PMC10490362 | ||
2.12. Fecal Sample DNA Extraction | The extraction of DNA from fecal samples was performed using the QIAamp Fast DNA Stool Mini kit (Qiagen, Hilden, Germany) in accordance with the manufacturer’s guidelines. Each extraction involved 200 ± 20 mg of feces as the starting material. Following purification, the isolated DNA was preserved at −80 °C until it wa... | PMC10490362 | ||
2.13. Quantitative Real-Time Polymerase Chain Reaction (qPCR) Analysis of Gut Microbiota DNA Concentration | In this study, the researchers aimed to quantify the concentration of gut microbiota DNA through quantitative real-time polymerase chain reaction (qPCR) analysis. The DNA concentration was determined by measuring the absorbance at 260 nm (A260), while its purity was assessed by calculating the A260/A280 ratio using a M... | PMC10490362 | ||
2.14. Analysis of Gut Microbiota | The sequencing of variable regions of the 16S rRNA gene of members of the Bacteria domains (V3–V4) was carried out by the company Argonne National LaboratoryFor alpha diversity analysis, the indices Chao1, Shannon, and Simpson were applied. Beta diversity was assessed by Principal Coordinate Analysis (PCoA) based on th... | PMC10490362 | ||
2.15. Statistical Analysis | For body composition, inflammatory markers, organic acids, fecal pH, and PCR, statistical analysis was performed using SPSS 20.0 software. The normality of the data was assessed by Shapiro–Wilk test. The average of each variable at the beginning and end of the intervention was compared using paired For analysis related... | PMC10490362 | ||
3. Results | overweight | Thirty-six men with overweight were recruited to the study. However, 12 did not meet the inclusion criteria; therefore, a total of 24 participants were included in study. Three participants left the study for personal reasons and twenty-one individuals finished the study ( | PMC10490362 | |
3.1. Anthropometric Measures and Inflammatory Markers | weight loss | Significant weight loss (−1.25 ± 0.84 kg, | PMC10490362 | |
3.2. SCFA Synthesis and Gut Microbiota PCR | We did not observe significant changes in fecal concentrations of acetic, propionic, and butyric acids after sorghum or wheat consumption for 8 weeks ( | PMC10490362 | ||
3.3. Gut Microbiota Analysis | ± | Sequencing the 16S rRNA gene from stool samples generated 1,383,378 raw sequences. After filtering and cleaning the sequences, 1,001,142 good-quality sequences were obtained. The Good’s coverage obtained in samples was >99%, indicating good sequencing coverage. Raw filtered reads and normalized read counts per group ar... | PMC10490362 | |
3.4. Functional Prediction Analysis (KEGG Analysis) | According to the intragroup KEGG metabolic pathway analysis, extruded sorghum SC319 consumption increased methyl ketone biosynthesis (By comparing the extruded sorghum and wheat group metabolic pathways using a KEGG intergroup analysis at the endpoint, it was found that sorghum consumption increased S-adenosyl-L-methio... | PMC10490362 | ||
3.5. LEfSe Analysis | All OTUs were analyzed by a Linear Discriminant Analysis of Effect Size (LEfSe) to identify the dominant cecal microbiota and intestinal biomarkers using taxonomy ( | PMC10490362 | ||
4. Discussion | inflammation, overweight, weight loss | CELIAC DISEASE, INFLAMMATION | This study investigated the effects of the consumption of extruded SC319 whole sorghum or extruded whole wheat associated with an 8-week daily 500 kcal energy restriction diet on the modulation of intestinal health with a focus on gut microbiota, short-chain fatty acid production, fecal pH, and weight loss and inflamma... | PMC10490362 |
5. Conclusions | overweight, weight loss | Consuming SC319 extruded sorghum allied to an energy restriction diet reduced body fat percentage in Brazilian men with overweight compared to control, with no differences in SCFA synthesis, fecal pH, α and β diversity, and inflammatory markers. In addition to this, considering gut microbiota functional prediction, the... | PMC10490362 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10490362 | ||
Author Contributions | Conceptualization, H.L., P.A., B.d.S. and H.M.; data curation, H.L., P.A., B.d.S., A.d.S., H.P.-S. and H.M.; formal analysis, H.L. and P.A.; funding acquisition, C.d.C., V.Q. and H.M.; investigation, H.L., P.A., B.d.S., A.d.S., H.P.-S. and H.M.; methodology, B.d.S., A.d.S., C.d.C., V.Q., H.P.-S. and H.M.; project admin... | PMC10490362 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Human Research Ethics Committee of the Federal University of Viçosa, Brazil (CAAE: 13630513.0.0000.5153), on 13 October 2014. | PMC10490362 | ||
Informed Consent Statement | All participants were informed about the objectives of the study and provided written informed consent. | PMC10490362 | ||
Data Availability Statement | Data presented in this study are available upon request to the corresponding author. The data are not publicly available due to the fact that they are available within an internal database of the research institution, therefore, they cannot be made publicly available. | PMC10490362 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10490362 | ||
Background | T2DM | HEART FAILURE, TYPE 2 DIABETES MELLITUS | The sodium-glucose co-transporter 2 inhibitor empagliflozin improves cardiovascular outcome in patients with type 2 diabetes mellitus (T2DM) and heart failure. Experimental studies suggest a direct cardiac effect of empagliflozin associated with an improvement in left ventricular diastolic function. | PMC10293456 |
Methods | T2DM | In the randomized, double-blind, two-armed, placebo-controlled, parallel group trial EmDia, patients with T2DM and elevated left ventricular | PMC10293456 | |
Results | T2DM | A total of 144 patients with T2DM and an elevated left ventricular | PMC10293456 | |
Conclusions | heart failure, T2DM | HEART FAILURE | Empagliflozin improves diastolic function in patients with T2DM and elevated end-diastolic pressure. Since the positive effects were consistent in patients with and without heart failure with preserved ejection fraction, the data add a mechanistic insight for the beneficial cardiovascular effect of empagliflozin. | PMC10293456 |
Trial registration | NCT02932436 | Clinicaltrials.gov, unique identifier: NCT02932436. | PMC10293456 | |
Graphical abstract | PMC10293456 | |||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00392-023-02164-w. | PMC10293456 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10293456 | ||
Introduction | type 2 diabetes mellitus, Diabetes mellitus | EPIDEMIC DISEASE, TYPE 2 DIABETES MELLITUS, DIABETES MELLITUS | Diabetes mellitus is an epidemic disease affecting more than 460 million people worldwide [The specific mechanisms mediating the beneficial effects of empagliflozin on cardiovascular outcome remain controversial [The EmDia trial was designed to evaluate the effect of empagliflozin compared to placebo on left ventricula... | PMC10293456 |
Methods | PMC10293456 | |||
Trial design | NCT02932436 | -11 | The EmDia trial is a randomized, double-blind, two-armed, placebo-controlled, parallel group, investigator-initiated study of phase IV. The University Medical Center of the Johannes Gutenberg-University Mainz conducted the single-center trial as study sponsor. All study documents were approved by the local ethics commi... | PMC10293456 |
Patient enrolment and randomization | type 2 diabetes mellitus, left ventricular diastolic dysfunction | TYPE 2 DIABETES MELLITUS, LEFT VENTRICULAR DIASTOLIC DYSFUNCTION | The main inclusion criteria of the EmDia trial were: (i) age from 18 to 84 years, (ii) diagnosis of type 2 diabetes mellitus with stable glucose-lowering background therapy and/or dietary treatment for at least 12 weeks, (iii) HbA1c ≥ 6.5% and ≤ 10.0% in subjects on antidiabetic background therapy or HbA1c ≥ 6.5% and ≤... | PMC10293456 |
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