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

Recruiting now

Conditions studied: Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, Retinopathy, Neuropathy, Nephropathy, Blood Pressure, Cardiovascular Risk, Microvascular

In brief

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.

Key facts

Study ID

NCT06837181

Run by

Jaeb Center for Health Research

People needed

200

Starts

2025-09-18

Expected to finish

2028-11-30

Last updated by the study team

2026-02-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• University of Colorado Denver — Aurora, Colorado, United States (enrolling)
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Columbia University Cystic Fibrosis Program — New York, New York, United States
• Atrium Health Wake Forest Baptist (Wake Forest Baptist) — Winston-Salem, North Carolina, United States
• Medical University of South Carolina — Charlestone, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• Massachusetts — Boston, Massachusetts, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California San Diego — San Diego, California, United States
• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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