Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)

Обзор

This multicenter cross-sectional study will include a diverse population of adolescents and adults with CF. The overall Aim is to describe prevalence of diabetes microvascular complications and macrovascular surrogates in people with established CFRD.

Вмешательства

• Другое observational study
  This is an observational study.

Первичные конечные точки

• Microvascular Complications [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Macrovascular Surrogates [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]

Вторичные конечные точки (12)

• PhenX English Proficiency [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• PhenX Food Security & Prescription Accessibility [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Exercise and Substance Use [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Pubertal Self-Assessment [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Beverage Questionnaire (BEVQ15) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• CFRD Care & Technology [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Diabetes Management Experience [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Problem Areas in Diabetes (PAID) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Problem Areas in Diabetes Parents of Teens (P-PAID-T) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Hypoglycemia Fear Survey (Child) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Hypoglycemia Fear Survey (Parent) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]
• Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry) [Срок оценки: From enrollment to the end of the participant's participation or 4 weeks]

Критерии участия

Критерии включения

• Written informed consent (and assent when applicable) obtained from participant or participant's legally authorized representative
• For Adults: Must be able to consent on one own's behalf (i.e., cannot lack cognitive capacity to consent due to the required patient-reported outcomes)
• Be willing and able to adhere to the study protocol requirements
• Age ≥ 12 years at time of enrollment
• CF diagnosis based on two CF causing mutations and/or positive sweat test according to CFF diagnostic criteria
• CFRD diagnosis ≥ 5 years at time of enrollment

Критерии исключения

• History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject
• History of transplant
• Pregnancy reported by participant at time of consent or at any point during active study participation

Pulse Wave Velocity Exclusion Criteria:

• Erratic, accelerated or mechanically controlled irregular heart rhythms including arrhythmias
• Carotid or aortic valve stenosis
• Peripheral artery disease or leg artery disease
• Generalized constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.
• Possible exclusions based on investigator medical provider assessment (additional precautions may be followed to allow inclusion):

• Pressure reading should not be conducted on a limb where there is intravenous access, arterio-venous shunt, or where circulation is compromised.
• Pressure reading should not be conducted on the side of the body that a mastectomy was done.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 18 центров

• University of Alabama at Birmingham — Birmingham
• Keck Medical Center of USC — Los Angeles
• Stanford University — Palo Alto
• University of California San Diego — San Diego
• University of Colorado Denver — Aurora
• University of Miami — Miami
• Emory University School of Medicine — Atlanta
• University of Iowa — Iowa City
• … и ещё 10 центров

Публикации

• Agbaje AO, Barker AR, Tuomainen TP. Differing Relations Of Arterial Stiffness And Carotid Intima-Media Thickness In Adolescence With Metabolic Risks In Young Adulthood: The ALSPAC Study. Circulation. 2021;144(Suppl_1):A13236-A. doi: doi:10.1161/circ.144.suppl_1.13236
• Kelly A, Magge SN, Walega R, Cochrane C, Pipan ME, Zemel BS, Cohen MS, Gidding SS, Townsend R. Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome. J Pediatr. 2019 Sep;212:79-86.e1. doi: 10.1016/j.jpeds.2019.04.059. Epub 2019 Jun 11. PMID 31201031
• DeLoach SS, Townsend RR. Vascular stiffness: its measurement and significance for epidemiologic and outcome studies. Clin J Am Soc Nephrol. 2008 Jan;3(1):184-92. doi: 10.2215/CJN.03340807. PMID 18178784
• Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994 Nov;17(11):1281-9. doi: 10.2337/diacare.17.11.1281. PMID 7821168
• Bergman M, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Apr;210:111636. doi: 10.1016/j.diabres.2024.111636. Epub 2024 Mar 25. No abstract available. PMID 38537890
• Bergman M, Manco M, Satman I, Chan J, Schmidt MI, Sesti G, Vanessa Fiorentino T, Abdul-Ghani M, Jagannathan R, Kumar Thyparambil Aravindakshan P, Gabriel R, Mohan V, Buysschaert M, Bennakhi A, Pascal Kengne A, Dorcely B, Nilsson PM, Tuomi T, Battelino T, Hussain A, Ceriello A, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosi PMID 38458916
• McGarry M. Transparency and diversity in cystic fibrosis research. Lancet. 2020 Aug 29;396(10251):601. doi: 10.1016/S0140-6736(20)30906-5. No abstract available. PMID 32861304
• Kartal Ozturk G, Conkar S, Eski A, Gulen F, Keskinoglu A, Demir E. Evaluation of increased arterial stiffness in pediatric patients with cystic fibrosis by augmentation index and pulse wave velocity analysis. Pediatr Pulmonol. 2020 May;55(5):1147-1153. doi: 10.1002/ppul.24688. Epub 2020 Feb 14. PMID 32057197

Идентификаторы

NCT: NCT06837181 · SPeCTRuM · 007365A124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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