Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM) (NCT06837181) | Clinical Trial Compass
RecruitingNot Applicable
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
United States200 participantsStarted 2025-09-18
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lim…
What they're measuring
1
Microvascular Complications
Timeframe: From enrollment to the end of the participant's participation or 4 weeks
2
Macrovascular Surrogates
Timeframe: From enrollment to the end of the participant's participation or 4 weeks