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

Launched by JAEB CENTER FOR HEALTH RESEARCH · Feb 14, 2025

Keywords

ClinConnect Summary

The clinical trial titled "Studying the Presence of CFRD Complications with Thoughtful Recruitment of Multiethnic Minoritized Groups" is looking to understand how common certain complications are in people with cystic fibrosis (CF) who also have cystic fibrosis-related diabetes (CFRD). This study will involve a diverse group of adolescents and adults, focusing on identifying complications that can affect their eyes, nerves, and kidneys, as well as their overall cardiovascular health. The goal is to gather important information that can help improve care for individuals living with these conditions.

To participate, individuals must be at least 12 years old, have a confirmed diagnosis of CF, and have been diagnosed with CFRD for more than five years. They should also be living in the United States and able to provide consent. Participants can expect to undergo various health assessments and provide information about their health experiences. It’s important to note that individuals with certain health issues or those who have had organ transplants may be excluded from the study. Overall, this trial aims to shed light on the health challenges faced by those with CF and CFRD, which could lead to better treatments and outcomes in the future.

Gender

ALL

Eligibility criteria

• 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.