NCT06837181 Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
| NCT ID | NCT06837181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jaeb Center for Health Research |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-09-18 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06837181 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06837181 currently recruiting?
Yes, NCT06837181 is actively recruiting participants. Contact the research team at jsibayan@jaeb.org for enrollment information.
Where is the NCT06837181 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Palo Alto, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT06837181 clinical trial?
NCT06837181 is sponsored by Jaeb Center for Health Research. The trial plans to enroll 200 participants.