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

NCT06837181 | Recruiting

• 2 other identifiers: SPeCTRuM007365A124
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

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

Keywords

Cystic Fibrosis; CFRD; Cystic Fibrosis-Related Diabetes; Observational; Physical Activity Tracker; Continuous glucose monitoring; CGM; Diabetes; blood pressure; cardiovascular risk; microvascular; diabetes complications; social determinants of health

Outcome Measures

Primary Outcomes (2)

• Microvascular Complications

  To describe the rates of microvascular complications (retinopathy, nephropathy, and peripheral neuropathy) and their relationships with HbA1c and diabetes duration in diverse cohort of adolescents and adults with CFRD for ≥5 years.

  From enrollment to the end of the participant's participation or 4 weeks

• Macrovascular Surrogates

  To describe macrovascular surrogates (resting blood pressure (BP), fasting lipids) and their relationship with HbA1c, diabetes duration and BMI in a diverse cohort with established CFRD.

  From enrollment to the end of the participant's participation or 4 weeks

Secondary Outcomes (18)

• PhenX English Proficiency

  From enrollment to the end of the participant's participation or 4 weeks

• PhenX Food Security & Prescription Accessibility

  From enrollment to the end of the participant's participation or 4 weeks

• Exercise and Substance Use

  From enrollment to the end of the participant's participation or 4 weeks

• Pubertal Self-Assessment

  From enrollment to the end of the participant's participation or 4 weeks

• Beverage Questionnaire (BEVQ15)

  From enrollment to the end of the participant's participation or 4 weeks

Other Outcomes (8)

• Exploratory Outcome - Participant diversity

  From enrollment to the end of the participant's participation or 4 weeks

• Cardiovascular sub-study - Pulse Wave Velocity and Pulse Wave Analysis (PWV & PWA)

  1 study visit day

• Exploratory Outcome - HbA1c and CGM metrics with nutritional intake

  3 days

Study Arms (1)

Individuals with Cystic Fibrosis-Related Diabetes

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

Other: observational study

Interventions

observational study OTHER

This is an observational study.

Individuals with Cystic Fibrosis-Related Diabetes

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with CFRD diagnosis ≥ 5 years at time of enrollment

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
• 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.
• 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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (18)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Keck Medical Center of USC

Los Angeles, California, 90033, United States

NOT YET RECRUITING

Stanford University

Palo Alto, California, 94304, United States

NOT YET RECRUITING

University of California San Diego

San Diego, California, 92103, United States

NOT YET RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Tulane University

New Orleans, Louisiana, 70112, United States

NOT YET RECRUITING

Massachusetts

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87106, United States

NOT YET RECRUITING

Columbia University Cystic Fibrosis Program

New York, New York, 10032, United States

NOT YET RECRUITING

Atrium Health Wake Forest Baptist (Wake Forest Baptist)

Winston-Salem, North Carolina, 27104, United States

NOT YET RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

Medical University of South Carolina

Charlestone, South Carolina, 29425, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (108)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and stool samples

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus; Retinal Diseases; Kidney Diseases; Diabetes Complications

Interventions

Observation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Judy Sibayan, MPH, CCRP

CONTACT

813-975-8690; jsibayan@jaeb.org

Haley Fonseca, PhD, RDN, LDN

CONTACT

813-975-8690; hfonseca@jaeb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 20, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (18)