Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Keywords

Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, Retinopathy, Neuropathy, Nephropathy, Blood Pressure, Cardiovascular Risk, Microvascular, Cystic Fibrosis, CFRD, Observational, Physical Activity Tracker, Continuous glucose monitoring, CGM, diabetes complications, social determinants of health, Diabetes Mellitus, Retinal Diseases, Kidney Diseases, Observation

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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.

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92103 United States
  • Keck Medical Center of USC not yet accepting patients
    Los Angeles California 90033 United States
  • Stanford University not yet accepting patients
    Palo Alto California 94304 United States
  • University of Colorado Denver accepting new patients
    Aurora Colorado 80045 United States
  • The University of Texas Health Science Center at San Antonio accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Jaeb Center for Health Research
ID
NCT06837181
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated