Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Purpose
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
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Individuals with Cystic Fibrosis-Related Diabetes | Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment |
|
Recruiting Locations
The University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
More Details
- Status
- Recruiting
- Sponsor
- Jaeb Center for Health Research