RECRUITINGOBSERVATIONAL
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Written willing to sign a consent form (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
Who Should NOT Join This Trial:
- 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 Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
observational study
This is an observational study.
Locations (18)
University of Alabama at Birmingham
Birmingham, Alabama, 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 Colorado Denver
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
Massachusetts
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, 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
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charlestone, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States