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

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

Recruiting
12 years and older
All
Phase N/A

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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.

Eligibility

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.

Study details
    Cystic Fibrosis (CF)
    Cystic Fibrosis-related Diabetes
    Diabetes
    Retinopathy
    Neuropathy
    Nephropathy
    Blood Pressure
    Cardiovascular Risk
    Microvascular

NCT06837181

Jaeb Center for Health Research

1 February 2026

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