observational study
OtherThis is an observational study.
NCT Number: NCT06837181
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.
Interested in participating?
Request Info12 year and older
All sexes
Observational
University of Alabama at Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pulse Wave Velocity Exclusion Criteria:
This is an observational study.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A self-evaluation questionnaire to assess child's pubertal development.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A questionnaire that asks the frequency and amount of beverage intake for the past month.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This is a questionnaire that asks participants regarding their CFRD care and the technology they use to help them manage diabetes.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This is a questionnaire that asks how participants manage their diabetes for the past 12 months.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Questionnaire that asks participants about possible diabetes-related issues they have experienced.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Questionnaire about what the parent or guardian of a participant may experience with their child's diabetes and rating how true it is for them over the past month.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A survey that consists of 25 questions and selecting from scale (0 = never to 4 = always) about how low blood sugar makes children feel and do.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Survey that consists of 25 questions about the frequency of things parents of children with diabetes sometimes do to keep from having low blood sugar.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A survey about various scenarios that may happen to the participant and rating how true it is for them over the past 6 months.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A 7 item scale that measures hypoglycemia awareness
Time frame: From enrollment to the end of the participant's participation or 4 weeks
A questionnaire that consists of 14 questions asking about the participant, their work and their home life.
Time frame: 3-10 days
This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This will be measured using the patient-related outcomes questionnaires.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Function will be assessed by collection of creatinine and Cystatin-C
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This will be measured by liver enzymes and complete blood count (CBC); APRI and EMR data for liver imaging
Time frame: From enrollment to the end of the participant's participation or 4 weeks
This will measure diversity of individuals who were approached for study inclusion, who were recruited, who consented and who partially or fully completed study procedures as well as barriers and facilitators to recruitment.
Time frame: 1 study visit day
A Sphygmocor XCEL device will be used to measure PWV/PWA (m/sec), pulse pressure amplification and augmentation index (Aix) and Aix adjusted to a HR of 75 (Aix-75).
Time frame: 3 days
The participant will complete 3-day recall of food intake using NIH's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Time frame: 3-10 days
The participant will be required to wear an accelerometer device for 3 to 10 days to assess physical activity.
Time frame: 24 hours
An oscillometric Spacelab monitors will be used to measure variables including SBP/DBP and BP load (%BP above 95th percentile for sex and height) for the 24-hour period and awake/sleep period. Sleep time will be determined from actigraphy and participant documentation.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Participant stool sample will be obtained for fecal elastase only for those for pancreatic sufficiency status is unclear.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Blood, urine and stool will be collected for biorepository.
Time frame: from enrollment
The study will use the participants' addresses or part of their addresses (such as their zip codes) to allow researchers to look at how where they live might be related to their health through geocoding.
Contact information is provided by the study sponsor or research team.
Haley Fonseca, PhD, RDN, LDN
CONTACT
Judy Sibayan, MPH, CCRP
CONTACT
Jaeb Center for Health Research
Other
Acronym: SPeCTRuM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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