Contemporary clinical trials最新文献_第5页

A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results 大肠癌有氧运动随机试验：原理、设计、招募和坚持锻炼的结果。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-01 DOI: 10.1016/j.cct.2024.107702

Stephanie L.E. Compton , Shengping Yang , Lauren S. Maniscalco , Reem A. Muhsen , Pratibha Shrestha , Xiaocheng Wu , Kaylee T. Woodard , Elizabeth R.M. Zunica , Eunhan Cho , Rachel L. Wall , John Brown , Anjana Jayaraman , Brian J. Kirby , L. Anne Gilmore , Frank L. Greenway , Guillaume Spielmann , Justin C. Brown

Background

Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, recruitment, and exercise adherence results of the National Cancer Institute (NCI)-sponsored Exercise and Colorectal Cancer Treatment (EXACT) trial.

Methods

The primary objective of the EXACT trial is to determine if randomization to 150 min per week of moderate-intensity aerobic exercise reduces systemic inflammation among stage I-III colorectal cancer survivors compared with a waitlist control group over 12 weeks. Participants were provided with an in-home treadmill and heart rate monitor. Characteristics associated with randomization were identified using χ² or Fisher's exact test for categorical variables and t-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed.

Results

Between August 2019 and February 2023, 3082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (P = 0.02), female sex (P = 0.002), white race (P = 0.01), proximal time since tumor resection (P = 0.02), and regional tumor stage (P < 0.001) were associated with study participation. Average exercise adherence was 92.2 % (95 % CI: 85.5, 98.8) and all study participants achieved ≥80 % exercise adherence. Endpoint data collection was completed for all participants in May 2023.

Conclusion

The results from the EXACT trial will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.

背景：体育锻炼与结直肠癌幸存者无病生存率的提高有关。本报告介绍了美国国立癌症研究所（NCI）发起的运动与结直肠癌治疗（EXACT）试验的目的、设计、招募和运动坚持情况：EXACT试验的主要目的是确定与候补对照组相比，随机安排每周150分钟的中等强度有氧运动是否能在12周内减少I-III期结直肠癌幸存者的全身炎症。研究人员为参与者提供了家用跑步机和心率监测器。对分类变量采用χ2或费雪精确检验，对随机化相关特征采用t检验或协方差分析（ANCOVA）。运动依从性以运动总分钟数乘以处方总分钟数计算：2019年8月至2023年2月期间，3082名结直肠癌幸存者受邀参加，89人接受了筛查，60人被随机分配到研究方案中。年龄较小（P = 0.02）、性别为女性（P = 0.002）、种族为白人（P = 0.01）、肿瘤切除术后近端时间（P = 0.02）和区域肿瘤分期（P 结论：EXACT试验的结果将在2019年8月至2023年2月期间公布：EXACT 试验的结果将描述运动所产生的变化，从而加深我们对运动可预防结直肠癌幸存者肿瘤复发和死亡的生物机制的了解。

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引用次数: 0

Family model diabetes self-management education and support in faith-based organizations in the Republic of the Marshall Islands: A study protocol 马绍尔群岛共和国信仰组织中的家庭模式糖尿病自我管理教育：研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-30 DOI: 10.1016/j.cct.2024.107705

Pearl A. McElfish , Sheldon Riklon , Jennifer A. Andersen , James P. Selig , Jonell Hudson , Williamina Ioanna Bing , Francyne Wase-Jacklick , Jack Niedenthal , Kyle Lemari , Henry Otuafi , Philmar Mendoza-Kabua , Joseph A. Henske , Dinesh Edem , Brett Rowland , Janine Boyers Schuh , Gail O'Connor , Mohammed Ason , Andy Bauleni , Britni L. Ayers

Introduction

The Republic of the Marshall Islands (RMI) is an independent nation and a member of the United States (US) Affiliated Pacific Islands through a Compact of Free Association. Health disparities in the RMI are striking, with high rates of type 2 diabetes mellitus (T2DM). The International Diabetes Federation has documented age-adjusted prevalence of T2DM at 23.0 %, compared to the US (13.2 %) and globally (9.8 %). T2DM has a devastating impact on patients and their families.

Methods

The purpose of this article is to present the study protocol for the fully powered two-arm cluster randomized controlled trial using a wait-list control to evaluate the effectiveness of a Family Diabetes Self-Management Education and Support (Family DSMES) program when delivered in a group setting by community health workers (CHWs) in faith-based organizations (FBOs) in the RMI. The study used a community engaged approach, and the study protocol includes adaptations based on the results of our one-arm pilot study.

Summary

This study will provide new and innovative information on the effectiveness of Family DSMES delivered in a group setting by CHWs in FBOs in the RMI. The knowledge gained from this research will inform DSMES interventions conducted with Marshallese and other Pacific Islander communities, as well as DSMES interventions conducted in other low-resource countries.

导言：马绍尔群岛共和国（马绍尔群岛）是一个独立国家，也是通过《自由联系条约》加入美国附属太平洋岛屿的成员。马绍尔群岛共和国在健康方面的差距非常明显，2型糖尿病（T2DM）的发病率很高。根据国际糖尿病联合会的记录，经年龄调整后的 T2DM 患病率为 23.0%，而美国为 13.2%，全球为 9.8%。T2DM 对患者及其家庭具有毁灭性影响：本文旨在介绍采用等待对照的双臂分组随机对照试验的研究方案，以评估家庭糖尿病自我管理教育和支持项目（Family Diabetes Self-Management Education and Support，FSMES）由马绍尔群岛的信仰组织（FBOs）中的社区卫生工作者（CHWs）在小组环境中实施的效果。这项研究采用了社区参与的方法，研究方案包括根据我们的单臂试点研究结果所做的调整。摘要：这项研究将提供新的创新信息，说明由马绍尔群岛宗教组织中的社区保健员在小组环境中开展家庭糖尿病管理教育和支持计划的有效性。从这项研究中获得的知识将为在马绍尔和其他太平洋岛民社区开展的DSMES干预措施以及在其他低资源国家开展的DSMES干预措施提供参考。

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引用次数: 0

Protocol of a randomized controlled trial into guided internet-delivered cognitive behavioral therapy for insomnia in autistic adults (i-Sleep Autism) 针对自闭症成人失眠症（i-Sleep Autism）的互联网指导认知行为疗法随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-30 DOI: 10.1016/j.cct.2024.107704

Kirsten L. Spaargaren , Sander M. Begeer , Kirstin Greaves-Lord , Heleen Riper , Annemieke van Straten

Background

Sleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population.

Methods

With this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (N = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators.

Conclusion

This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention.

Trial registration: NL-OMON56692.

背景：睡眠问题，尤其是失眠，在成年自闭症患者中非常普遍，约占 60%，严重影响了他们的生活质量。基于互联网的失眠认知行为疗法（iCBT-I）可以提供方便、可扩展的治疗。鉴于自闭症患者独特的感官和信息处理能力以及社交障碍，量身定制的治疗方法对解决睡眠问题至关重要。然而，专门针对成人自闭症患者开发和测试的干预措施却很少。要满足自闭症人群对有效失眠治疗的迫切需求，填补这一空白至关重要：通过这项双臂、平行、优势随机对照试验，我们将评估针对患有自闭症和失眠症的成人（N = 160）的指导性 iCBT-I 干预（i-Sleep Autism）的有效性。i-Sleep Autism 是在现有干预措施（i-Sleep）的基础上调整而成。纳入标准为：年龄≥18岁，确诊为自闭症，失眠程度至少低于阈值（失眠严重程度指数≥10）。参与者被随机分配到 i-Sleep Autism 或仅提供信息的候补对照组（在线心理教育和睡眠卫生）。6 周后，对照组接受干预。失眠严重程度是主要结果。次要结果包括睡前唤醒、一般心理健康、抑郁、焦虑、日常功能和生活质量。评估将在基线、干预中期（3 周）、干预后（6 周）和 6 个月随访时进行（干预组）。采用线性混合效应回归模型来评估 i-Sleep Autism 的有效性，同时探讨潜在的调节因素和中介因素：这项试验可以揭示患有失眠症的自闭症成人是否能从有指导的电子健康干预中受益：试验注册：NL-OMON56692。

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引用次数: 0

Racial and ethnic representation of youth in type 1 diabetes interventional trials 1 型糖尿病干预试验中青年的种族和民族代表性。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-29 DOI: 10.1016/j.cct.2024.107703

Emilie S. Zoltick, Ann Chen Wu, Mei-Sing Ong

Background

Underrepresentation of racial and ethnic groups in clinical trials can limit generalizability of research findings and equitable access to treatment. This study evaluates racial and ethnic representation of youth in US-based interventional trials on childhood type 1 diabetes (T1D).

Methods

This cross-sectional study examined interventional trials of T1D conducted in the US and registered on ClinicalTrials.gov. Trials were included if completed as of June 6, 2023, began between years 2010 and 2022, and exclusively enrolled youth ≤19 years old. We assessed representation of racial and ethnic groups in T1D trials, estimated using the enrollment-prevalence difference (EPD).

Results

A total of 106 trials were eligible for inclusion. Of those eligible, 62 (58 %) trials reported participant race or ethnicity and were included in the analyses. Significant disparities in enrollment were observed for American Indian/Alaska Native, Asian/Pacific Islander, Black, and Hispanic youth compared to their respective contribution to disease burden among youth in the US. Disparities in trial enrollment were greatest for Black (EPD, −10.2; 95 % confidence interval [CI], −14.4 to −7.9) and Hispanic (EPD, −7.7; 95 % CI, −12.6 to −4.8) youth. EPDs of trials conducted prior to year 2017 did not differ significantly from those conducted as of year 2017.

Conclusions

Historically marginalized racial and ethnic youth were underrepresented in T1D trials. Strategies to improve recruitment of these populations are needed to reduce inequities in diabetes treatment and outcomes.

背景：种族和民族群体在临床试验中的代表性不足会限制研究结果的普遍性和公平获得治疗的机会。本研究评估了美国儿童 1 型糖尿病（T1D）干预试验中青年的种族和民族代表性：这项横断面研究考察了在美国进行并在 ClinicalTrials.gov 上注册的 1 型糖尿病干预试验。如果试验是在 2023 年 6 月 6 日之前完成的，在 2010 年至 2022 年期间开始的，并且只招募了年龄小于 19 岁的青少年，则纳入这些试验。我们评估了T1D试验中种族和民族群体的代表性，并使用入组-患病率差异（EPD）进行了估算：结果：共有 106 项试验符合纳入条件。结果：共有 106 项试验符合纳入条件，其中 62 项（58%）试验报告了参与者的种族或民族，并纳入了分析。美国印第安人/阿拉斯加原住民、亚裔/太平洋岛民、黑人和西班牙裔青少年的试验登记人数与他们各自在美国青少年疾病负担中所占的比例相比存在显著差异。黑人（EPD，-10.2；95% 置信区间[CI]，-14.4 至 -7.9）和西班牙裔（EPD，-7.7；95% 置信区间[CI]，-12.6 至 -4.8）青少年的试验注册率差距最大。2017年之前进行的试验的EPD与截至2017年进行的试验的EPD没有显著差异：历史上被边缘化的种族和民族青年在T1D试验中的代表性不足。需要制定策略来改善这些人群的招募情况，以减少糖尿病治疗和结果中的不公平现象。

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引用次数: 0

Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes 行业赞助的儿科临床药物试验启动和注册流程存在严重延误

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-24 DOI: 10.1016/j.cct.2024.107701

Angie Price , Hannah Simmons , Emily Gehring , Lauren Davis , Gwyneth Fischer , Ann R. Klipsch , Erin Richmond , Janice E. Sullivan , Steven J. Steiner

Background

Significant barriers to advancing pediatric drug development continue despite federal incentives to expedite pediatric drug development. There is an urgent need to improve how clinical trials are designed, implemented, and conducted to increase the number of approved therapeutic interventions for children.

Methods

The Pediatric Improvement Collaborative for Clinical Trials & Research was created to measure timelines and address delays in the pediatric clinical trials process. This multi-site collaborative prospectively monitored sixteen time points in industry-sponsored pediatric clinical drug trials, including times to budget approval, contract execution, ancillary protocol review, Institutional Review Board approval, Site Initiation Visit, and first patient consented.

Results

Twenty-four sites contributed data on 330 industry-sponsored pediatric drug studies. The average duration to final study budget approval was 121 (range 3–585) days, to final study Institutional Review Board (IRB) approval was 51 (range 1–205) days, to Site Initiation Visit was 204 (range 23–600) days, and to first patient consented was 239 (range 30–534) days.

Conclusion

Significant study start-up delays were noted in industry-sponsored clinical drug trials among a large group of pediatric sites. Delays and wide variation in all steps of the study process indicate multiple opportunities for improvement.

背景尽管联邦政府鼓励加快儿科药物开发，但推进儿科药物开发的重大障碍依然存在。我们迫切需要改进临床试验的设计、实施和进行方式，以增加获批的儿童治疗干预措施的数量。方法儿科临床试验与amp; 研究改进合作组织的成立是为了衡量儿科临床试验过程中的时间节点并解决延误问题。这个多研究机构合作组织对行业赞助的儿科临床药物试验中的 16 个时间点进行了前瞻性监测，包括从预算批准、合同执行、辅助方案审查、机构审查委员会批准、研究机构启动访问到首例患者同意的时间。最终研究预算批准的平均时间为 121 天（范围为 3-585 天），最终研究机构审查委员会 (IRB) 批准的平均时间为 51 天（范围为 1-205 天），研究机构启动访问的平均时间为 204 天（范围为 23-600 天），首次患者同意的平均时间为 239 天（范围为 30-534 天）。研究过程中所有步骤的延误和巨大差异表明有多种改进机会。

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引用次数: 0

Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial 合作治愈初级保健中的成瘾和心理健康（CHAMP）：2a 型混合试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-23 DOI: 10.1016/j.cct.2024.107700

John C. Fortney , Anna D. Ratzliff , Brittany E. Blanchard , Lori Ferro , Julien Rouvere , Erin Chase , Mark H. Duncan , Joseph O. Merrill , Tracy Simpson , Emily C. Williams , Elizabeth J. Austin , Geoffrey M. Curran , Michael Schoenbaum , Patrick J. Heagerty , Andrew J. Saxon

Background

The gold-standard treatment for opioid use disorder (OUD) is medication for OUD (MOUD). However, less than a quarter of people with OUD initiate MOUD. Expanding the Collaborative Care Model (CoCM) to include primary care patients with OUD could improve access to and initiation of MOUD. This paper presents the methods and baseline sample characteristics of a Hybrid Type 2a trial comparing the effectiveness of CoCM for OUD and co-occurring mental health symptoms (MHS) to CoCM for MHS only.

Method

42 primary care clinics were cluster randomized and 254 primary care patients with OUD and elevated MHS were enrolled. Recruitment was terminated early by the Data and Safety Monitoring Board for futility. Participants completed research assessments at baseline, 3 months, and 6 months. The multiple primary outcomes were past-month number of days of nonmedical opioid use and SF12 Mental Health Component Summary (MCS) scores.

Results

MCS scores were over a standard deviation below the national mean (M = 34.5). Nearly half (47.6 %) of participants had previously overdosed in their lifetimes. Three quarters (76.0 %) were already being prescribed MOUD at baseline, only 30.4 % reported non-medical use of opioids, and only 33.9 % reported being bothered by opioid cravings.

Conclusion

The unexpectedly high proportion of enrollees already prescribed MOUD at baseline indicates that most patients were in the maintenance rather than acute phase of treatment. Challenges identifying and enrolling patients in the acute phase of OUD treatment implies that intervention effectiveness will depend on its success preventing the discontinuation of MOUD rather than initiating MOUD.

背景：治疗阿片类药物使用障碍（OUD）的黄金标准是药物治疗 OUD（MOUD）。然而，只有不到四分之一的阿片类药物使用障碍患者开始接受药物治疗。将协作护理模式（CoCM）扩展至阿片类药物使用障碍的初级保健患者，可以改善阿片类药物使用障碍患者获得和开始药物治疗的情况。本文介绍了一项混合型 2a 试验的方法和基线样本特征，该试验比较了 CoCM 对治疗 OUD 和并发精神健康症状 (MHS) 的有效性，以及 CoCM 对仅治疗 MHS 的有效性：对 42 家初级保健诊所进行随机分组，招募了 254 名患有 OUD 和精神健康症状加重的初级保健患者。数据与安全监控委员会以无效为由提前终止了招募。参与者在基线、3 个月和 6 个月时完成了研究评估。多个主要结果是上个月非医疗使用阿片类药物的天数和 SF12 心理健康成分汇总（MCS）得分：MCS 分数比全国平均值（M = 34.5）低一个标准差以上。近一半（47.6%）的参与者在其一生中曾吸毒过量。四分之三（76.0%）的受试者在基线时已被处方鸦片制剂，只有 30.4% 的受试者报告非医疗使用阿片类药物，只有 33.9% 的受试者报告受到阿片类药物渴求的困扰：基线时已服用 MOUD 的患者比例出乎意料地高，这表明大多数患者处于维持治疗阶段，而非急性治疗阶段。在识别和招募处于阿片类药物治疗急性期的患者方面存在挑战，这意味着干预的有效性将取决于能否成功防止患者停用咀嚼片，而不是启动咀嚼片治疗。

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引用次数: 0

Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial 通过提高营养获得率解决糖尿病问题（ADELANTE）--一种改善拉丁裔糖尿病患者家庭粮食不安全和血糖控制的多层次方法：随机对照试验。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-23 DOI: 10.1016/j.cct.2024.107699

Marcela D. Radtke , Wei-Ting Chen , Lan Xiao , Patricia Rodriguez Espinosa , Marcela Orizaga , Tainayah Thomas , Elizabeth Venditti , Amy L. Yaroch , Kenia Zepada , Lisa G. Rosas , June Tester

Background

Latinx adults are disproportionately impacted by the interrelated challenges of food insecurity and nutrition sensitive chronic diseases. Food and nutrition insecurity can exacerbate the development and progression of chronic diseases, such as diabetes. Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.

Methods

This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (n = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI > 25 kg/m²), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.

Conclusions

The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. The mixed-method approach will also identity the reach of this ‘Food is Medicine’ intervention on additional household members to inform diabetes prevention efforts.

Clinical Trial Registration: NCT05228860

背景：拉丁裔成年人受到粮食不安全和营养敏感性慢性病等相互关联的挑战的影响尤为严重。粮食和营养不安全会加剧糖尿病等慢性疾病的发展和恶化。需要采取可持续的有效干预措施来改善拉丁裔人口的粮食不安全状况和糖尿病管理：这项混合型 1 类试验评估了多层次干预措施的效果，其中包括在 6 个月内对血红蛋白 A1c（HbA1c）这一主要结果实施医疗支持性食物和行为生活方式计划。患有 2 型糖尿病（HbA1c 为 6.0-12.0%）、超重/肥胖（体重指数大于 25 kg/m2）且自我报告有粮食不安全风险的拉美裔成年人（n = 355）将按 1:1 的比例随机分配到干预组（每周 12 次提供蔬菜、水果和全谷物食品 + 文化上改进的行为生活方式计划）与对照组（延迟 6 个月后提供食品）。结果评估将在 0 个月、6 个月和 12 个月进行，包括 HbA1c、饮食摄入量、社会心理健康结果和糖尿病相关压力因素。此外，还将评估食物不安全状况以及干预措施对最多两名家庭成员的影响。将根据 "覆盖、效果、采用、实施和维护"（RE-AIM）框架对患者、医疗服务提供者和社区合作伙伴进行定性访谈，以确定未来推广的障碍和最佳实践：结论：ADELANTE 试验将为多层次干预措施对拉丁裔成年人糖尿病相关结果的有效性提供新的见解。混合方法还将确定这种 "食物即药物 "干预措施对更多家庭成员的影响，为糖尿病预防工作提供信息：临床试验注册：NCT05228860。

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引用次数: 0

Does cancer clinical trial enrollment for sexual and gender minority people differ from heterosexual, cisgender people? 性少数群体和性别少数群体的癌症临床试验注册与异性恋、同性别的人有区别吗？

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-18 DOI: 10.1016/j.cct.2024.107695

Ash B. Alpert , Juno Obedin-Maliver , Annie Gjelsvik , Siraj Amanullah , Theresa I. Shireman , John R. Blosnich

Background

Sexual and gender minority (SGM) people experience cancer disparities compared to heterosexual and cisgender (non-SGM) people and likely have barriers to cancer clinical trial enrollment. Data are sparse, however, regarding cancer clinical trial enrollment for SGM versus non-SGM people.

Methods

Using data from the 2020 Behavioral Risk Factor Surveillance Survey (BRFSS), we applied a logistic regression to assess associations between SGM status and clinical trial enrollment for 346 SGM and 9441 non-SGM people diagnosed with cancer. The model was adjusted for age at diagnosis, race/ethnicity, partnership status, education, employment, and sex assigned at birth.

Results

SGM individuals had 94 % greater odds than non-SGM individuals to report participation in a clinical trial (aOR 1.94; 95 % CI 1.02–3.68) after adjusting for other factors.

Conclusions

Data from the BRFSS suggest that SGM people with cancer have higher odds of clinical trial enrollment compared to non-SGM people with cancer. Future work is needed to prospectively track oncology treatment, including clinical trial participation, and outcomes of SGM people versus non-SGM people with cancer. Other studies will be needed to develop and implement systematic, consistent, and non-stigmatizing sexual orientation and gender identity data collection methods.

背景：与异性恋和同性（非 SGM）人群相比，性少数群体和性别少数群体（SGM）人群在癌症治疗方面存在差异，他们在癌症临床试验注册方面可能存在障碍。然而，有关 SGM 与非 SGM 人癌症临床试验注册情况的数据却很少：利用 2020 年行为风险因素监测调查（BRFSS）的数据，我们对 346 名被诊断患有癌症的 SGM 和 9441 名非 SGM 患者进行了逻辑回归，以评估 SGM 状态与临床试验注册之间的关系。该模型根据诊断时的年龄、种族/民族、伴侣状况、教育程度、就业情况和出生时的性别进行了调整：结果：在对其他因素进行调整后，SGM 患者报告参与临床试验的几率比非 SGM 患者高 94%（aOR 1.94；95 % CI 1.02-3.68）：来自 BRFSS 的数据表明，与非 SGM 癌症患者相比，SGM 癌症患者参加临床试验的几率更高。今后还需要开展工作，对 SGM 癌症患者与非 SGM 癌症患者的肿瘤治疗（包括临床试验的参与）和结果进行前瞻性跟踪。还需要开展其他研究，以制定和实施系统、一致、无污名化的性取向和性别认同数据收集方法。

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引用次数: 0

Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial 限时进食与现行营养学实践对 2 型糖尿病高危人群血糖控制和心血管代谢结果的影响：多中心、平行分组、非劣效随机对照试验方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-17 DOI: 10.1016/j.cct.2024.107696

Rasha Charrouf , Evelyn B. Parr , Amy T. Hutchison , Steve A. Flint , Xiao Tong Teong , Gary Wittert , Andrew D. Vincent , Leah Brennan , Brooke L. Devlin , John A. Hawley , Leonie K. Heilbronn

Background

Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.

Hypothesis

TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).

Methods

This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35–70 years, with a body mass index (BMI) >25 but <45 kg/m², and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.

Outcomes

The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. Other endpoints are exploratory and will not be adjusted for multiplicity.

Conclusions

We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.

Trial registration: NCT04762251; 21 Feb 2021.

背景限时进食（TRE）是一种可改善代谢健康的饮食策略。方法这项平行分组、随机、非劣效对照试验将 247 名参与者按地点和糖化血红蛋白（HbA1c）随机分为 TRE 或 CP（1:1），为期 12 个月。参与者年龄在 35-70 岁之间，体重指数 (BMI) 为 25-45 kg/m2，澳大利亚 2 型糖尿病风险评估 (AUSDRISK) 得分≥15 分，未确诊为 2 型糖尿病。研究访问在各组之间均衡进行，所有参与者都在 0、0.5、1、2 和 3 个月时接受了五次咨询。结果主要终点是对分层因素和性别进行协变量线性回归调整后，4 个月时各组 HbA1c 平均差异（TRE vs CP）的估计值。4 个月和 12 个月时的次要疗效结果是空腹血糖、空腹胰岛素、HOMA-IR 和夜间血糖的变化（通过连续血糖监测仪的曲线下增量面积），以及 12 个月时 HbA1c 的变化。结论我们将确定 TRE 是否是当前营养学实践中改善血糖控制的替代策略：试验注册：NCT04762251；2021 年 2 月 21 日。

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引用次数: 0

Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial 间歇性禁食促进全身甘油三酯代谢重编程（IFAST）：前瞻性随机对照试验的设计与方法。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-09-17 DOI: 10.1016/j.cct.2024.107698

Jacob A. Quaytman , Natalie L. David , Sharini Venugopal , Tânia Amorim , Britney Beatrice , Frederico G.S. Toledo , Rachel G. Miller , Matthew L. Steinhauser , Pouneh K. Fazeli

Background

Caloric restriction prolongs lifespan in model organisms and improves metrics of aging-related diseases in humans, but daily compliance is challenging. Intermittent fasting improves metrics of lipid and glucose metabolism in the setting of weight loss but whether these metrics are improved independent of weight loss is not known.

Methods

We seek to address this gap with IFAST, a single-center, three-arm, prospective, randomized, controlled clinical trial. Eligible study participants are adults with no chronic medical conditions beyond prediabetes or overweight but who are at high risk for type 2 diabetes mellitus (T2D), defined as having a history of gestational diabetes or a first-degree relative with T2D. Participants will be randomized in a 1:2:2 schema to either a control group, a fasting group, or a fasting/weight maintenance group. The fasting groups will complete a 24-h fast one day per week for 12 weeks. The key mechanistic endpoint is change in triglyceride composition (defined by carbon content and degree of saturation) as measured by longitudinal metabolomics. The key safety endpoint is percent change from baseline in bone volume fraction (BV/TV; high-resolution peripheral quantitative CT) at the radius in the fasting group. Secondary endpoints include measures of insulin sensitivity (hyperinsulinemic-euglycemic clamp), clinical lipid profiling, systemic inflammation markers, hunger assessment, bone density, and bone microarchitecture with high-resolution peripheral quantitative CT.

Conclusion

IFAST will investigate intrinsic metabolic benefits of intermittent fasting beyond weight loss.

Trial registration

ClinicalTrials.gov ID NCT05722873.

背景：热量限制可延长模式生物的寿命，并改善人类衰老相关疾病的指标，但每日达标具有挑战性。间歇性禁食能在减轻体重的情况下改善脂质和葡萄糖代谢指标，但这些指标的改善是否与体重减轻无关尚不清楚：IFAST是一项单中心、三臂、前瞻性、随机对照临床试验。符合条件的研究参与者是除了糖尿病前期或超重之外没有其他慢性疾病，但有 2 型糖尿病（T2D）高风险的成年人，即有妊娠糖尿病史或一级亲属患有 T2D。参与者将按 1:2:2 的比例随机分配到对照组、禁食组或禁食/体重维持组。禁食组将在 12 周内每周有一天禁食 24 小时。关键的机理终点是通过纵向代谢组学测量甘油三酯成分的变化（以碳含量和饱和度定义）。关键的安全性终点是禁食组桡骨小梁骨量与基线相比的百分比变化。次要终点包括胰岛素敏感性测量（高胰岛素血糖钳夹）、临床脂质分析、全身炎症标志物、饥饿评估、骨密度和高分辨率外周定量 CT 骨微结构：试验注册：试验注册：ClinicalTrials.gov ID NCT05722873。

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引用次数: 0