RecruitingNCT06837181
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Sponsor
Jaeb Center for Health Research
Enrollment
200 participants
Start Date
Sep 18, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 12 Years
Inclusion Criteria6
- 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 Criteria10
- 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
- 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.
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Interventions
OTHERobservational study
This is an observational study.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT06837181
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