Menu
Recruiting NCT06837181

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

— Observational Cystic Fibrosis (CF) Cystic Fibrosis-related Diabetes Diabetes Retinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational study.
Who it may be relevant to
Registry conditions: Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, Retinopathy. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other observational study
    This is an observational study.

Primary outcome measures

  • Microvascular Complications [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Macrovascular Surrogates [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
Secondary outcome measures (12)
  • PhenX English Proficiency [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • PhenX Food Security & Prescription Accessibility [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Exercise and Substance Use [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Pubertal Self-Assessment [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Beverage Questionnaire (BEVQ15) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • CFRD Care & Technology [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Diabetes Management Experience [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Problem Areas in Diabetes (PAID) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Problem Areas in Diabetes Parents of Teens (P-PAID-T) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Hypoglycemia Fear Survey (Child) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Hypoglycemia Fear Survey (Parent) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]
  • Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry) [Time frame: From enrollment to the end of the participant's participation or 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 18 centers
  • 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
  • … and 10 more centers

Publications

  • 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

Identifiers

NCT: NCT06837181 · SPeCTRuM · 007365A124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗