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NCT06837181Recruiting

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

Jaeb Center for Health Research

Start Date

9/18/2025

Completion Date

11/30/2028

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

Age Range: 12 years to No maximum

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.

Interventions

OTHER

observational study

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Conditions

Cystic Fibrosis (CF)Cystic Fibrosis-related DiabetesDiabetesRetinopathyNeuropathyNephropathyBlood PressureCardiovascular RiskMicrovascular

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Keck Medical Center of USC

Los Angeles, California 90033

United States

Stanford University

Palo Alto, California 94304

United States

University of California San Diego

San Diego, California 92103

United States

University of Colorado Denver

Aurora, Colorado 80045

United States

University of Miami

Miami, Florida 33136

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

University of Iowa

Iowa City, Iowa 52242

United States

Tulane University

New Orleans, Louisiana 70112

United States

Massachusetts

Boston, Massachusetts 02114

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

University of New Mexico

Albuquerque, New Mexico 87106

United States

Columbia University Cystic Fibrosis Program

New York, New York 10032

United States

Atrium Health Wake Forest Baptist (Wake Forest Baptist)

Winston-Salem, North Carolina 27104

United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19146

United States

Medical University of South Carolina

Charlestone, South Carolina 29425

United States

Baylor College of Medicine

Houston, Texas 77030

United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States