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

Jaeb Center for Health Research

Status: Enrolling

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

Treatments: Other: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06837181

007365A124 (Other Grant/Funding Number)

SPeCTRuM

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Individuals with Cystic Fibrosis-Related Diabetes

Description:

Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment

Treatment:

Other: observational study