No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Jaeb Center for Health Research · Other
Who this trial is looking for
This trial is looking for adolescents and adults with cystic fibrosis and diabetes. Participants will be helping researchers understand complications related to their diabetes.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 12 years old.
I have been diagnosed with cystic fibrosis.
I have been diagnosed with cystic fibrosis-related diabetes for at least 5 years.
I can provide consent for myself, or I have permission from a representative.
I agree to follow the study rules.
You may not be able to join if
I have had a transplant.
I am pregnant.
I have a medical condition that could affect the study results.
I have irregular heart rhythms.
I have severe narrowing of my heart valves.
I have arterial disease in my legs.
I have specific artery constrictions.
I am unable to have specific pressure readings done.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Facility
City
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Status
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 ou…
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.
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