Trials最新文献

{"title":"Metformin versus insulin in glycemic control in pregnancy (MevIP): a randomized clinical trial protocol.","authors":"Carolina Freitas Alves Amaral-Moreira, Daiane Sofia Morais Paulino, Belmiro G Pereira, Patricia Moretti Rehder, Fernanda G Surita","doi":"10.1186/s13063-025-08752-7","DOIUrl":"10.1186/s13063-025-08752-7","url":null,"abstract":"<p><strong>Background: </strong>Gestational diabetes is one of the most prevalent diseases in pregnancy, with an incidence of 5 to 18% in Brazil, and is associated with high morbidity rates. The first-line treatment is insulin, although some recent studies have indicated that metformin might also be effective. Metformin is safe in pregnancy and appears to produce better results than insulin, including reduced gestational weight gain (GWG) and smaller gestational-age newborns. Few studies have been conducted on this topic in low- and middle-income countries.</p><p><strong>Methods: </strong>We designed an open randomized controlled trial comparing two treatments for pregnant women with type II diabetes mellitus (DM) and gestational diabetes (DMG): the metformin group (intervention) and the insulin group (as a routine service). The primary outcome is glycemic control. The secondary outcomes are GWG, the occurrence of hypertensive syndromes, macrosomia, and neonatal hypoglycemia. The sample will comprise 92 pregnant women, 46 per group. The inclusion criteria will be GDM or type II DM requiring medication for glycemic control, singleton pregnancy, and gestational age under 34 weeks. The exclusion criteria will be current treatment with any medication for glycemic control, type I DM, and intolerance to the study medications (metformin or insulin). Women will be routinely followed during antenatal care, childbirth, and the postpartum period. Statistical analyses will include the intention-to-treat approach and a comparison between the two groups.</p><p><strong>Discussion: </strong>Considering the Brazilian socioeconomic reality and the safety of metformin demonstrated in previous trials, we expect that the MevIP study will demonstrate that metformin is an adequate and appropriate medication for GDM treatment in the Brazilian population, representing an alternative to insulin for GDM.</p><p><strong>Trial registration: </strong>This protocol has been registered prospectively in ReBEC under the ID RBR-3j3cktx in August 11, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"45"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11807315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain.","authors":"Yenisel Cruz-Almeida, Soamy Montesino-Goicolea, Pedro Valdes-Hernandez, Zhiguang Huo, Roland Staud, Natalie C Ebner","doi":"10.1186/s13063-024-08715-4","DOIUrl":"10.1186/s13063-024-08715-4","url":null,"abstract":"<p><strong>Background: </strong>Osteoarthritis (OA) is the leading cause of disability among older adults with the knee being the most affected joint. Specifically, there is an urgent need to develop better analgesics for individuals with OA-related pain, since currently used analgesics frequently fail to provide adequate relief or must be discontinued owing to adverse effects. A promising treatment is the neuropeptide oxytocin (OT), which has been shown to play a role in endogenous analgesia with human and animal studies demonstrating anti-nociceptive effects. The primary aims of the study are to examine preliminary analgesic effects of a chronic OT intervention in community-dwelling older individuals with chronic knee osteoarthritis pain.</p><p><strong>Methods: </strong>In this article, we describe the rationale and design of the Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE) study, a double-blinded intervention in which 80 participants over 45 years of age with knee osteoarthritis pain will be recruited to participate in a cross-over trial of 4 weeks of intranasal oxytocin or placebo administration. Primary study outcomes include preliminary changes in pain intensity and interference as well as multi-modal assessment batteries including circulating biomarkers and neuroimaging measures. Self-reported and quantitative outcomes will be assessed at baseline, post-intervention periods, and up to a 6-month follow-up period.</p><p><strong>Discussion: </strong>This study will establish preliminary effectiveness of a novel intervention in middle to older aged adults with knee osteoarthritis pain. Achievement of these aims will provide a rich platform for future intervention research targeting improvements in pain and disability among geriatric populations and will serve as a foundation for a fully powered trial to examine treatment efficacy and potential mechanisms of the proposed intervention.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03878589. Registered on March 18th, 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"44"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11806790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143371282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antisecretory factor in severe traumatic brain injury (AFISTBI): protocol for an exploratory randomized placebo-controlled trial.","authors":"Linus Réen, David Cederberg, Niklas Marklund, Edward Visse, Peter Siesjö","doi":"10.1186/s13063-025-08760-7","DOIUrl":"10.1186/s13063-025-08760-7","url":null,"abstract":"<p><strong>Background: </strong>Despite recent advances in neuroimaging and neurocritical care, severe traumatic brain injury (TBI) is still a major cause of severe disability and mortality, with increasing incidence worldwide. Antisecretory factor (AF), commercially available as Salovum®, has been shown to lower intracranial pressure (ICP) in experimental models of, e.g., TBI and herpes encephalitis. The aim of this study is to assess the effect of antisecretory factors in adult patients with severe TBI on ICP and inflammatory mediators in extracellular fluid and plasma.</p><p><strong>Methods/design: </strong>This is a single-center, randomized, placebo-controlled clinical phase 2 trial, investigating the clinical superiority of Salovum® given as a food supplement during 5 days to adults with severe TBI (Glasgow Coma Scale (GCS) < 9), admitted to the neurocritical intensive care unit (NICU) at Skane university hospital, Lund, Sweden. All patients with GCS < 9 and clinical indication for insertion of ICP-monitor and microdialysis catheter will be screened for inclusion and assigned to either the treatment group (n = 10) or placebo group (n = 10). In both groups, the primary outcome will be ICP (mean values and change from baseline during intervention), registered from high-frequency data monitoring for 5 days. Secondary outcomes will be inflammatory mediators in plasma and intracerebral microdialysis perfusate days 1, 3, and 5 during trial treatment.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04117672. Registered on September 17, 2017. Protocol version 6 from October 24, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"43"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11804074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143371261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-inferiority study to compare the efficacy of relugolix with dienogest for endometriosis-associated pain and usefulness of administering relugolix prior to dienogest (READY study): study protocol for a multicenter randomized controlled study.","authors":"Fuminori Taniguchi, Motoko Fukui, Yutaka Osuga, Tasuku Harada, Jo Kitawaki","doi":"10.1186/s13063-025-08750-9","DOIUrl":"10.1186/s13063-025-08750-9","url":null,"abstract":"<p><strong>Background: </strong>Endometriosis presents as endometrial tissue growths outside the uterine cavity with its major symptoms including dysmenorrhea and infertility. Progestin preparations, such as dienogest, are the first-line therapy for endometriosis symptoms, but may cause abnormal uterine bleeding. A gonadotropin-releasing hormone (GnRH) agonist may also be used to ease symptoms, but may induce flare-ups. Relugolix is a non-peptide GnRH antagonist that does not induce flare-ups. This study aims to compare the efficacy of relugolix with that of dienogest for reducing endometriosis-associated pain, and to evaluate if relugolix, administered prior to dienogest, decreases abnormal uterine bleeding.</p><p><strong>Methods: </strong>A multicenter, open-label, active-controlled, non-inferiority randomized study will be conducted at 11 sites in Japan. A total of 100 premenopausal patients aged ≥ 18 years with endometriosis, a maximum visual analog scale (VAS) score > 30 for endometriosis-associated pain, and dysmenorrhea or pelvic pain of at least moderate severity on the Biberoglu & Behrman (B&B) scale will be randomized in a 1:1 ratio to either a relugolix group or dienogest group. Patients in the relugolix group will receive 40 mg oral relugolix once daily for 16 weeks, followed by 1 mg oral dienogest twice daily for 24 weeks. Patients in the dienogest group will receive oral dienogest 1 mg twice daily for 24 weeks. The primary outcome will be change in maximum VAS score for endometriosis-associated pain from baseline to 13-16 weeks after start of treatment. The secondary outcomes will include VAS score for dyspareunia, B&B score for dysmenorrhea, severity of induration in the pouch of Douglas, restricted uterine mobility, pelvic tenderness, quality of life, analgesic use, and ovarian endometrioma diameter. The safety outcomes will include treatment-emergent adverse events, bone density, bone markers, menstrual status, genital bleeding, and endometrial thickness.</p><p><strong>Discussion: </strong>This study will determine the efficacy of relugolix for improving endometriosis-associated pain and dienogest-induced abnormal uterine bleeding. The results will support treatment decisions regarding endometriosis-associated pain, and the introduction of new treatments to reduce dienogest-induced abnormal uterine bleeding.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials ID jRCTs061230064. Registered on 29 September 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"41"},"PeriodicalIF":2.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11800467/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes-statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial.","authors":"Sophie Zaloumis, Matthew J Summers, Jeffrey J Presneill, Rinaldo Bellomo, Lee-Anne S Chapple, Marianne J Chapman, Adam M Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J Maiden, Stephanie N O'Connor, Sandra L Peake, Emma J Ridley, An Tran-Duy, Patricia J Williams, Paul J Young, Amalia Karahalios","doi":"10.1186/s13063-025-08759-0","DOIUrl":"10.1186/s13063-025-08759-0","url":null,"abstract":"<p><strong>Background: </strong>The TARGET Protein trial will evaluate the effect of greater enteral protein delivery (augmented protein) on clinical outcomes of critically ill adult patients when compared to usual care.</p><p><strong>Objective: </strong>To describe the statistical analysis plan for the TARGET Protein trial.</p><p><strong>Methods: </strong>TARGET Protein is a cluster randomized, cross-sectional, double cross-over, open-label, registry-embedded, pragmatic clinical trial conducted across Australia and New Zealand. The trial randomized eight intensive care units (ICU) to receive enteral formula containing either higher dose enteral protein (augmented protein) or usual dose protein in a 1:1 ratio. Each ICU received one trial formula for a 3-month period and then switched to the alternate formulae. This sequence was repeated, for a total trial length of 12 months. The primary outcome is the number of days free of the index hospital and alive at day 90. Secondary outcomes include proportion of patients alive at day 90, survivor-only analysis of days free of the index hospital at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. The statistical methods and models which will be used to estimate the effects for the primary and secondary outcomes are described. All statistical models will account for the cluster-randomized cross-over design to ensure correct estimation of the 95% confidence intervals. Trial enrolment is complete with 3412 patients enrolled. Data linkage is ongoing.</p><p><strong>Conclusion: </strong>This statistical analysis plan enables transparent reporting of the TARGET Protein trial. It will reduce the risk of potential selective reporting biases.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"42"},"PeriodicalIF":2.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11800547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting.","authors":"Jae Eun Shin, Juho Choi, Heejung Lee, Suk-Won Lee, Juhwan Oh","doi":"10.1186/s13063-025-08735-8","DOIUrl":"10.1186/s13063-025-08735-8","url":null,"abstract":"<p><strong>Background: </strong>Chronic diseases such as diabetes and hypertension pose significant health and economic challenges globally, and South Korea is no exception. Innovative digital health services have the potential to revolutionize chronic disease management by providing patients with real-time, personalized care and empowering them to take an active role in their health. There is a critical need to evaluate the effectiveness of such services. This protocol describes a randomized controlled trial that evaluates the effectiveness of an online-to-offline (O2O) digital healthcare service for patients with chronic diseases, specifically diabetes and hypertension, in Pyeongchang-gun.</p><p><strong>Methods: </strong>This study presents a comprehensive protocol for the assessment of an online-to-offline (O2O) digital health service model aimed at managing chronic diseases. The study consists of two main groups of participants: those with diabetes and those with hypertension. Participants are randomized into treatment and control arms for each group. The intervention includes personalized digital healthcare support, continuous data monitoring, and online education, with primary care provided by healthcare professionals. To evaluate the primary and secondary outcomes-such as HbA1c, systolic blood pressure, and cholesterol levels-the study applies a range of statistical methods. These include intention-to-treat (ITT) analysis to account for all randomized participants, regression models to estimate the treatment effect, and adjustments for baseline covariates to improve precision. Subgroup analyses will explore variations in treatment effects based on factors such as intervention intensity, comorbidity, and healthcare provider.</p><p><strong>Discussion: </strong>This protocol outlines a novel approach to evaluating the O2O digital health service model for chronic disease management. It offers insights into the nuanced effects of the intervention, highlighting the potential for tailoring future interventions for maximum benefit. By assessing its real-world effectiveness, this study can inform healthcare policies, expand the application scope of O2O service models, and identify additional chronic diseases that can benefit from digital health services. This research bridges the gap between theory and practice, contributing to evidence-based healthcare decision-making and improving patient outcomes in the era of digital health.</p><p><strong>Trial registration: </strong>This study is registered at ClinicalTrials.gov of the US National Library of Medicine. The registration number is NCT06150508, and the registered date is 2023-11-29.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"40"},"PeriodicalIF":2.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11800493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of educational intervention based on the mobile application on women's knowledge, attitude, and practice on microplastics and health: study protocol for a randomized controlled trial.","authors":"Zahra Seifi, Fatemeh Zarei, Fazlollah Ahmadi","doi":"10.1186/s13063-025-08742-9","DOIUrl":"10.1186/s13063-025-08742-9","url":null,"abstract":"<p><strong>Background: </strong>The pervasive issue of microplastic (MP) contamination is undeniable. The primary solution to this global problem lies in significantly reducing the amount of plastic entering the environment. Addressing such a large-scale issue is no easy feat. However, a necessary strategy involves public education. In parallel, a randomized controlled trial (RCT) aims to evaluate the effect of interventional education via a mobile phone application on improving women's knowledge, attitude, and practice regarding the health effects of MPs.</p><p><strong>Methods: </strong>This randomized controlled trial includes three phases. In the first phase, a questionnaire assessing women's knowledge, attitudes, and practices (KAP) regarding microplastics will be developed and validated. In phase two, educational content for the mobile application \"PlastiWise\" will be created based on behavior change constructs. In phase three, a two-arm, parallel-design RCT will be conducted with 136 women aged 18 years and older who own smartphones, have basic literacy skills, and provide informed consent. Participants will be recruited through an online call disseminated via social media platforms and health system networks in Iran. They will be randomly assigned to an intervention group (n = 68) receiving the educational program through the app or a control group (n = 68). The sample size was calculated using G*Power software to ensure sufficient power (80%) with an alpha level of 0.05, factoring in a 15% dropout rate. Primary outcome data (KAP scores) will be collected at baseline, immediately post-intervention, and 8 weeks post-intervention using self-reported questionnaires. Data analysis will include descriptive statistics and inferential tests, such as independent t-tests and paired t-tests, to assess group differences and within-group changes over time.</p><p><strong>Discussion: </strong>Implementing an educational intervention on knowledge, attitude, and practice (KAP) about MPs using a mobile application will be a first in Iran. This research is expected to benefit Iranian women by contributing evidence on factors that might influence the effectiveness of educational training related to MP consumption. TRIAL STATUS : Protocol version 1, 2024-07-12. The enrolment of participants began on 2024-09-22. The recruitment is estimated to be completed by 2024-11-21. TRIAL REGISTRATION : Iranian Clinical Trial Register IRCT20240529061941N1. https://irct.behdasht.gov.ir/user/trial/77069/view . Date is July 12, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"39"},"PeriodicalIF":2.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11796146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing vaccine clinical trials participation among elderly: challenges and strategies.","authors":"Paul Gillard, Samer Nakhle, Darin Brimhall, Ouzama Henry, Narcisa Mesaros","doi":"10.1186/s13063-025-08754-5","DOIUrl":"10.1186/s13063-025-08754-5","url":null,"abstract":"<p><p>As the fastest growing demographic worldwide, the elderly population is projected to reach nearly 1 billion by 2030 and double the 2022 number by 2050. Despite being the largest consumers of medications, they have been historically underrepresented in clinical trials. However, we are witnessing a promising shift as their participation in trials is on the rise. In fact, recent megatrials enrolling more than 30,000 elderly participants demonstrated the feasibility of large-scale clinical trials involving this very specific population. However, unique challenges, including multi-morbidities, frailty, and ethically sound informed consent in those with cognitive deficits, require continuous careful reassessments and flexibility. Creative and tailored strategies are of paramount importance to bolster elderly trial participation. This paper highlights challenges and shares our experiences on novel methods and success stories associated with the enrollment and retention of elderly individuals in clinical trials. Successful tactics to balance the burden of clinical trial participation with its benefits encompass regular contact, family and friends' engagement, making travel easier or unnecessary, use of digital tools, and building relationships with community organizations. Through innovative strategies that consider the unique needs and limitations of this population, we can achieve successful participation in clinical trials. This will lead to more effective treatments and interventions for our growing elderly population.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"38"},"PeriodicalIF":2.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How to improve the quality of euglycemic glucose clamp tests in long-acting insulin studies.","authors":"Yi Yang, Fu Kuang, XueYing Zhu, Li Li, Yao Huang, Yang Liu, Xian Yu","doi":"10.1186/s13063-025-08749-2","DOIUrl":"10.1186/s13063-025-08749-2","url":null,"abstract":"<p><strong>Background: </strong>The euglycemic clamp test stands as the best method for assessing the pharmacokinetic and pharmacodynamic properties of long-acting insulin. However, despite its widespread use, there remains a notable absence of an established gold standard for evaluating the test's quality. Existing recommendations from regulatory agencies lack specific threshold values, particularly concerning long-acting insulin. This study aimed to determine the evaluation criteria for assessing the quality of the long-acting insulin euglycemic glucose clamp test and to improve the overall quality of this testing method.</p><p><strong>Methods: </strong>Fifty-three healthy volunteers were administered a single dose of insulin degludec (0.4 IU/kg) and underwent a 24-h euglycemic clamp test. Blood samples were collected to evaluate the pharmacokinetics and pharmacodynamics of insulin degludec. Volunteers were separated into group A (coefficient of variation in blood glucose [CVBG] ≤ 3.5%) and group B (CVBG > 3.5%). The quality difference of the clamp test between the groups was assessed using various quality control indices. Volunteers were also categorized into group C (C-peptide reduction rate < 50%) and group D (C-peptide reduction rate ≥ 50%). The clamp test quality, pharmacokinetics, and pharmacodynamics of groups C and D were compared.</p><p><strong>Results: </strong>According to CVBG, group A had a mean CVBG of 2.95%, group B had a mean CVBG of 4.15%, and group A had a significantly lower CVBG than group B (p < 0.001). CVBG was positively correlated with other quality control indicators, such as the percentage of glucose excursion from the target range (GEFTR), duration of GEFTR, and area under the curve (AUC) of GEFTR. According to the reduction of C-peptide levels: group D had significantly higher C-peptide reduction than group C (p < 0.001). Groups C and D had CVBG < 3.5%. The quality of groups C and groups D was evaluated by the quality control indicators of the clamp test. Only the AUC of GEFTR was statistically different between Groups C and D (p = 0.043, < 0.05), and there was no statistical difference in other indicators between the two groups.</p><p><strong>Conclusions: </strong>CVBG could be used as a standard for evaluating the quality of long-acting insulin euglycemic glucose clamp test, and the test quality was superior with a CVBG ≤ 3.5%. A C-peptide reduction ratio ≥ 50% indicated sufficient endogenous insulin inhibition; however, when the glucose fluctuation is small (CVBG is maintained at a low level) during the clamp test, even if the clamp test quality is slightly different, it is not sufficient to interfere with endogenous insulin secretion.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"37"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of vitamin E supplementation on sperm analysis in varicocelectomy patients: a triple-blind randomized controlled trial.","authors":"Kasra Saeedian, Saeed Davaryar, Maryam Emadzadeh, Alireza Akhavan Rezayat","doi":"10.1186/s13063-025-08740-x","DOIUrl":"10.1186/s13063-025-08740-x","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the impact of vitamin E supplementation on sperm analysis results in patients post-varicocelectomy.</p><p><strong>Martials and method: </strong>This single-center, triple-blind, randomized controlled trial was conducted at Imam Reza Hospital, Mashhad, Iran. Ninety male patients, aged 15-25 years, with infertility and varicocele grade 2 or 3, were randomized into two groups. The intervention group received 400 units of vitamin E daily for 3 months, while the control group received a placebo. Sperm analysis was conducted before and 3 months after the intervention. Statistical analyses were performed using SPSS version 23, with significance set at P < 0.05.</p><p><strong>Results: </strong>A total of 90 patients were enrolled and equally randomized into two groups (n = 45 per group). The mean age was 30.68 ± 6.31 years. Post-intervention, the improvement in sperm motility was significantly higher in the vitamin E group compared to the placebo group (P = 0.03). Both groups showed significant improvements in sperm motility, count, and morphology from pre- to post-intervention (P < 0.001).</p><p><strong>Conclusion: </strong>Vitamin E supplementation post-varicocelectomy is associated with improved sperm parameters, suggesting potential benefits in the management of male infertility related to varicocele. However, varicocelectomy alone also results in significant improvements.</p><p><strong>Trial registration: </strong>This study is registered at the Iranian Registry of Clinical Trials (IRCT20200911048689N1). Registered on October 10, 2020.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"36"},"PeriodicalIF":2.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11786367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}