研究CFRD并发症的存在，并进行了周到的多种族少数化（Spectrum）组的募集 (SPeCTRuM)
2026年2月9日 更新者：Jaeb Center for Health Research
这项多中心横断面研究将包括种族和种族多样化的青少年和CF成年人。
总体目的是描述既定CFRD患者的糖尿病微血管并发症和大血管替代的患病率。
研究概览
研究类型
观察性的
注册 (估计的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Judy Sibayan, MPH, CCRP
- 电话号码：813-975-8690
- 邮箱：jsibayan@jaeb.org
研究联系人备份
- 姓名：Haley Fonseca, PhD, RDN, LDN
- 电话号码：813-975-8690
- 邮箱：hfonseca@jaeb.org
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35233
- 尚未招聘
- University of Alabama at Birmingham
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接触：
- George Solomon
- 电话号码：205-638-5599
- 邮箱：gsolomon@uabmc.edu
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California
-
Los Angeles、California、美国、90033
- 尚未招聘
- Keck Medical Center of USC
-
接触：
- Adupa Rao
- 电话号码：323-442-8522
- 邮箱：Purush.Rao@med.usc.edu
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Palo Alto、California、美国、94304
- 尚未招聘
- Stanford University
-
接触：
- Carlos Milla
- 电话号码：650-721-1132
- 邮箱：cmilla@stanford.edu
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San Diego、California、美国、92103
- 尚未招聘
- University of California San Diego
-
接触：
- Jacob Bailey
- 电话号码：858-246-0371
- 邮箱：jbailey@health.ucsd.edu
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Colorado
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Aurora、Colorado、美国、80045
- 招聘中
- University of Colorado Denver
-
接触：
- Christine Chan, MD
- 电话号码：720-777-6128
- 邮箱：christinel.chan@childrenscolorado.org
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Florida
-
Miami、Florida、美国、33136
- 尚未招聘
- University of Miami
-
接触：
- Maria Tupayachi Ortiz
- 电话号码：305-799-9209
- 邮箱：mtupayachiortiz@med.miami.edu
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Georgia
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Atlanta、Georgia、美国、30322
- 招聘中
- Emory University School of Medicine
-
接触：
- Tanicia Daley, MD MPH
- 电话号码：404-727-2503
- 邮箱：tanicia.daley@emory.edu
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Iowa
-
Iowa City、Iowa、美国、52242
- 尚未招聘
- University of Iowa
-
接触：
- Katie Larson Ode, MD
- 电话号码：319-356-4443
- 邮箱：Katie-larsonode@uiowa.edu
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Louisiana
-
New Orleans、Louisiana、美国、70112
- 尚未招聘
- Tulane University
-
接触：
- Ross Klingsberg
- 电话号码：504-400-4316
- 邮箱：rklingsb@tulane.edu
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Massachusetts
-
Boston、Massachusetts、美国、02114
- 尚未招聘
- Massachusetts
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接触：
- Melissa Putman
- 邮箱：MSPUTMAN@mgh.harvard.edu
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Minnesota
-
Minneapolis、Minnesota、美国、55455
- 招聘中
- University of Minnesota
-
接触：
- Amir Moheet, MD
- 电话号码：617-624-3209
- 邮箱：mohee002@umn.edu
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New Mexico
-
Albuquerque、New Mexico、美国、87106
- 尚未招聘
- University of New Mexico
-
接触：
- Kamyron Jordan
- 电话号码：505-272-9889
- 邮箱：KDJordan@salud.unm.edu
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New York
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New York、New York、美国、10032
- 尚未招聘
- Columbia University Cystic Fibrosis Program
-
接触：
- Hossein Sadeghi
- 电话号码：212-305-5122
- 邮箱：hs762@cumc.columbia.edu
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North Carolina
-
Winston-Salem、North Carolina、美国、27104
- 尚未招聘
- Atrium Health Wake Forest Baptist (Wake Forest Baptist)
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接触：
- Chad Marion
- 电话号码：336-713-8550
- 邮箱：Chad.Marion@wfusm.edu
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Pennsylvania
-
Philadelphia、Pennsylvania、美国、19146
- 招聘中
- The Children's Hospital of Philadelphia
-
接触：
- Andrea Kelly, MD
- 电话号码：215-590-3174
- 邮箱：kellya@chop.edu
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South Carolina
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Charlestone、South Carolina、美国、29425
- 尚未招聘
- Medical University of South Carolina
-
接触：
- Christina Mingora
- 电话号码：843-792-3163
- 邮箱：mingora@musc.edu
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Texas
-
Houston、Texas、美国、77030
- 尚未招聘
- Baylor College of Medicine
-
接触：
- Michelle Mann
- 电话号码：8328224772
- 邮箱：mcmann@texaschildrens.org
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San Antonio、Texas、美国、78229
- 招聘中
- The University of Texas Health Science Center at San Antonio
-
接触：
- Maria Rayas, MD
- 电话号码：210-567-5283
- 邮箱：rayas@uthscsa.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
在入学日期之前诊断出患有囊性纤维化相关糖尿病的人超过5年
描述
纳入标准：
- 从参与者或参与者的合法授权代表那里获得的书面知情同意书（并在适用的情况下同意）
- 对于成年人：必须能够代表一个人同意（即，由于所需的患者报告的结果，不能缺乏认知能力同意）
- 愿意并且能够遵守研究方案要求
- 入学时的年龄≥12岁
- 根据CFF诊断标准，基于两个CF的CF诊断，导致突变和/或阳性汗液测试
- 在入学日期之前诊断出5年以上的CFRD
- 住在美国
排除标准：
- 研究人员认为，任何疾病或病史都可能将研究结果混淆或对受试者构成额外的风险
- 移植历史
- 参与者在同意时或在积极研究期间的任何时候报告的怀孕
脉冲波速度排除标准：
- 不良，加速或机械控制的不规则心律，包括心律不齐
- 颈动脉或主动脉瓣狭窄
- 周围动脉疾病或腿部动脉疾病
- 肌肉导管动脉的广义收缩或局部痉挛，例如低温心肺旁路手术或伴随Raynaud的现象或强烈的感冒后立即看到。
根据调查员医疗提供者评估的可能排除（可能遵循其他预防措施以允许包含）：
- 压力读数不应在静脉内通道，动脉连接或循环损害的肢体上进行压力读数。
- 不应在身体侧进行压力读取，以进行乳房切除术。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
患有囊性纤维化相关糖尿病的人
在入学前诊断为囊性纤维化相关糖尿病的人超过5年
|
这是一项观察性研究。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
微血管并发症
大体时间：从参加者的招生到参与者的参与或4周
|
描述微血管并发症的速率（视网膜病，肾病和周围神经病）及其与CFRD的青少年和成年人在不同队列中与HBA1C和糖尿病持续时间的关系≥5年。
|
从参加者的招生到参与者的参与或4周
|
|
大血管替代
大体时间：从参加者的招生到参与者的参与或4周
|
描述大血管替代物（静息血压（BP），禁食脂质）及其与HBA1C的关系，糖尿病持续时间和BMI与已建立的CFRD的多样队列中。
|
从参加者的招生到参与者的参与或4周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
苯二苯克斯的能力
大体时间：从参加者的招生到参与者的参与或4周
|
该问卷将用于描述研究人群中健康的社会决定因素及其与微血管并发症的横断面关系，将在很大程度上探索大血管并发症。
|
从参加者的招生到参与者的参与或4周
|
|
苯克斯粮食安全和处方可访问性
大体时间：从参加者的招生到参与者的参与或4周
|
该问卷将用于描述研究人群中健康的社会决定因素及其与微血管并发症的横断面关系，将在很大程度上探索大血管并发症。
|
从参加者的招生到参与者的参与或4周
|
|
锻炼
大体时间：从参加者的招生到参与者的参与或4周
|
该问卷提出了有关参与者的体育锻炼，睡眠习惯和吸毒物质的问题。
|
从参加者的招生到参与者的参与或4周
|
|
青春期的自我评估
大体时间：从参加者的招生到参与者的参与或4周
|
评估儿童青春期发展的自我评估问卷。
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从参加者的招生到参与者的参与或4周
|
|
饮料问卷（BEVQ15）
大体时间：从参加者的招生到参与者的参与或4周
|
一份问卷，询问过去一个月的饮料摄入量的频率和量。
|
从参加者的招生到参与者的参与或4周
|
|
CFRD护理与技术
大体时间：从参加者的招生到参与者的参与或4周
|
这是一份问卷调查表，向参与者询问其CFRD护理以及他们用来帮助他们管理糖尿病的技术。
|
从参加者的招生到参与者的参与或4周
|
|
糖尿病管理经验
大体时间：从参加者的招生到参与者的参与或4周
|
这是一份问卷，询问参与者在过去12个月中如何管理糖尿病。
|
从参加者的招生到参与者的参与或4周
|
|
糖尿病的问题区域（付费）
大体时间：从参加者的招生到参与者的参与或4周
|
问卷调查询问参与者有关他们遇到的可能与糖尿病有关的问题。
|
从参加者的招生到参与者的参与或4周
|
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青少年糖尿病父母的问题区域（P-PAID-T）
大体时间：从参加者的招生到参与者的参与或4周
|
关于参与者的父母或监护人的问卷调查表可能会经历孩子的糖尿病，并评估过去一个月对他们的真实程度。
|
从参加者的招生到参与者的参与或4周
|
|
低血糖恐惧调查（儿童）
大体时间：从参加者的招生到参与者的参与或4周
|
一项由25个问题组成的调查，并从规模（0 =永远= 4 =总是）选择低血糖使孩子的感觉和做。
|
从参加者的招生到参与者的参与或4周
|
|
低血糖恐惧调查（父母）
大体时间：从参加者的招生到参与者的参与或4周
|
调查包括25个问题，内容涉及糖尿病儿童的父母的频率有时会避免低血糖。
|
从参加者的招生到参与者的参与或4周
|
|
低血糖恐惧调查（成人毛发表格）/忧虑（HFS-II-Worry）
大体时间：从参加者的招生到参与者的参与或4周
|
一项有关参与者可能发生的各种情况的调查，并评估过去6个月对他们的真实情况。
|
从参加者的招生到参与者的参与或4周
|
|
黄金分数
大体时间：从参加者的招生到参与者的参与或4周
|
7项量表，可衡量低血糖意识
|
从参加者的招生到参与者的参与或4周
|
|
我们所有人
大体时间：从参加者的招生到参与者的参与或4周
|
一份问卷由14个问题组成，询问参与者，他们的工作和家庭生活。
|
从参加者的招生到参与者的参与或4周
|
|
连续葡萄糖监测（CGM）定义的血糖控制（时间范围内，时间限制范围，时间寄生范围，葡萄糖变异性）以及CGM指标与HBA1C之间的关系，在拥有已建立的人群中CFRD
大体时间：3-10天
|
这将使用连续的葡萄糖监测仪来测量，该葡萄糖监测仪将由参与者佩戴3至10天。
|
3-10天
|
|
参与者的多样性和入学障碍
大体时间：从参加者的招生到参与者的参与或4周
|
这将使用与患者相关的结果问卷进行衡量。
|
从参加者的招生到参与者的参与或4周
|
|
EGFR的肾功能
大体时间：从参加者的招生到参与者的参与或4周
|
功能将通过收集肌酐和胱抑素C来评估
|
从参加者的招生到参与者的参与或4周
|
|
肝功能
大体时间：从参加者的招生到参与者的参与或4周
|
这将通过肝酶和全血细胞计数（CBC）来测量；肝脏成像的APRI和EMR数据
|
从参加者的招生到参与者的参与或4周
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
探索性结果 - 参与者的多样性
大体时间：从参加者的招生到参与者的参与或4周
|
这将衡量被招募的人的多样性，被招募，同意，部分或完全完成的学习程序以及障碍和促进者招募的人的多样性。
|
从参加者的招生到参与者的参与或4周
|
|
心血管次级研究 - 脉搏波速度和脉搏波分析（PWV和PWA）
大体时间：1个学习访问日
|
SPHYGMOCOR XCEL设备将用于测量PWV/PWA（M/SEC），脉压扩增和增强指数（AIX）和AIX调整为HR的HR（AIX-75）。
|
1个学习访问日
|
|
探索结果-HBA1C和CGM指标具有营养摄入量
大体时间：3天
|
参与者将使用NIH的24小时自动化自动管理（ASA24）饮食评估工具来完成为期3天的食物摄入量。
|
3天
|
|
探索性结果-HBA1C和CGM指标具有体育锻炼
大体时间：3-10天
|
参与者将被要求佩戴加速度计设备3至10天以评估体育锻炼。
|
3-10天
|
|
心血管副研究 - 门诊血压监测
大体时间：24小时
|
在24小时期间，将使用示波测量线虫监测器来测量包括SBP/DBP和BP负载（性别和身高高于第95个百分位数的％BP）的变量。
睡眠时间将由艺术学和参与者文档确定。
|
24小时
|
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粪便收集
大体时间：从参加者的招生到参与者的参与或4周
|
粪便弹性酶将仅获得胰腺弹性酶的粪便样品，仅针对胰腺充足状态的粪便样本尚不清楚。
|
从参加者的招生到参与者的参与或4周
|
|
生物座位的样本收集
大体时间：从参加者的招生到参与者的参与或4周
|
将收集血液，尿液和粪便以进行生物验证。
|
从参加者的招生到参与者的参与或4周
|
|
用于地理编码的信息收集
大体时间：自入组
|
该研究将使用参与者的地址或部分地址（例如邮政编码），通过地理编码让研究人员了解他们的居住地可能与健康存在何种关联。
|
自入组
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
- Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.
- Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. doi: 10.1210/jc.2006-2190. Epub 2007 Apr 24.
- Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.
- Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.
- Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, Butt AA, Bidwell Goetz M, Leaf D, Oursler KA, Rimland D, Rodriguez Barradas M, Brown S, Gibert C, McGinnis K, Crothers K, Sico J, Crane H, Warner A, Gottlieb S, Gottdiener J, Tracy RP, Budoff M, Watson C, Armah KA, Doebler D, Bryant K, Justice AC. HIV infection and the risk of acute myocardial infarction. JAMA Intern Med. 2013 Apr 22;173(8):614-22. doi: 10.1001/jamainternmed.2013.3728.
- Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Drevinek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordonez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185.
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- Nichols DP, Paynter AC, Heltshe SL, Donaldson SH, Frederick CA, Freedman SD, Gelfond D, Hoffman LR, Kelly A, Narkewicz MR, Pittman JE, Ratjen F, Rosenfeld M, Sagel SD, Schwarzenberg SJ, Singh PK, Solomon GM, Stalvey MS, Clancy JP, Kirby S, Van Dalfsen JM, Kloster MH, Rowe SM; PROMISE Study group. Clinical Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in People with Cystic Fibrosis: A Clinical Trial. Am J Respir Crit Care Med. 2022 Mar 1;205(5):529-539. doi: 10.1164/rccm.202108-1986OC.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年9月18日
初级完成 (估计的)
2028年11月30日
研究完成 (估计的)
2028年11月30日
研究注册日期
首次提交
2025年1月29日
首先提交符合 QC 标准的
2025年2月14日
首次发布 (实际的)
2025年2月20日
研究记录更新
最后更新发布 (实际的)
2026年2月10日
上次提交的符合 QC 标准的更新
2026年2月9日
最后验证
2026年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SPECTRUM
- 007365A124 (其他赠款/资助编号：Cystic Fibrosis Foundation)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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