Cystic Fibrosis (CF)SPeCTRuMNCT06837181
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
An observational study of Cystic Fibrosis (CF) and Cystic Fibrosis-related Diabetes, run by Jaeb Center for Health Research at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes
- What is being tested?
- observational study
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- 18 Sep 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with CFRD diagnosis ≥ 5 years at time of enrollment
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Not yet recruiting
University of New Mexico
Albuquerque, New Mexico, 87106
Kamyron Jordan, 505-272-9889, KDJordan@salud.unm.edu
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Tanicia Daley, MD MPH, 404-727-2503, tanicia.daley@emory.edu
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Christine Chan, MD, 720-777-6128, christinel.chan@childrenscolorado.org
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
George Solomon, 205-638-5599, gsolomon@uabmc.edu
- Not yet recruiting
Massachusetts
Boston, Massachusetts, 02114
Melissa Putman, MSPUTMAN@mgh.harvard.edu
- Not yet recruiting
Medical University of South Carolina
Charlestone, South Carolina, 29425
Christina Mingora, 843-792-3163, mingora@musc.edu
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Michelle Mann, 8328224772, mcmann@texaschildrens.org
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Katie Larson Ode, MD, 319-356-4443, Katie-larsonode@uiowa.edu
- Not yet recruiting
Keck Medical Center of USC
Los Angeles, California, 90033
Adupa Rao, 323-442-8522, Purush.Rao@med.usc.edu
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Maria Tupayachi Ortiz, 305-799-9209, mtupayachiortiz@med.miami.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Amir Moheet, MD, 617-624-3209, mohee002@umn.edu
- Not yet recruiting
Tulane University
New Orleans, Louisiana, 70112
Ross Klingsberg, 504-400-4316, rklingsb@tulane.edu
- Not yet recruiting
Columbia University Cystic Fibrosis Program
New York, New York, 10032
Hossein Sadeghi, 212-305-5122, hs762@cumc.columbia.edu
- Not yet recruiting
Stanford University
Palo Alto, California, 94304
Carlos Milla, 650-721-1132, cmilla@stanford.edu
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Andrea Kelly, MD, 215-590-3174, kellya@chop.edu
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Maria Rayas, MD, 210-567-5283, rayas@uthscsa.edu
- Not yet recruiting
University of California San Diego
San Diego, California, 92103
Jacob Bailey, 858-246-0371, jbailey@health.ucsd.edu
- Not yet recruiting
Atrium Health Wake Forest Baptist (Wake Forest Baptist)
Winston-Salem, North Carolina, 27104
Chad Marion, 336-713-8550, Chad.Marion@wfusm.edu
About this study
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
- Being tested
- observational study
- 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
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus, Retinal Diseases, Kidney Diseases, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Cystic Fibrosis-Related Diabetes | Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Secondary outcomes (18)
PhenX English Proficiency
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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
PhenX Food Security & Prescription Accessibility
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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Exercise and Substance Use
This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Pubertal Self-Assessment
A self-evaluation questionnaire to assess child's pubertal development.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Beverage Questionnaire (BEVQ15)
A questionnaire that asks the frequency and amount of beverage intake for the past month.
Measured: From enrollment to the end of the participant's participation or 4 weeks
CFRD Care & Technology
This is a questionnaire that asks participants regarding their CFRD care and the technology they use to help them manage diabetes.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Diabetes Management Experience
This is a questionnaire that asks how participants manage their diabetes for the past 12 months.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes (PAID)
Questionnaire that asks participants about possible diabetes-related issues they have experienced.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes Parents of Teens (P-PAID-T)
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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Child)
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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Parent)
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.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry)
A survey about various scenarios that may happen to the participant and rating how true it is for them over the past 6 months.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Gold Score
A 7 item scale that measures hypoglycemia awareness
Measured: From enrollment to the end of the participant's participation or 4 weeks
All of Us
A questionnaire that consists of 14 questions asking about the participant, their work and their home life.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Continuous glucose monitoring (CGM)-defined glycemic control (time-in-range, time-above-range, time-below-range, glucose variability), and the relationships between CGM metrics and HbA1c, in a diverse population of people with established CFRD
This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days.
Measured: 3-10 days
Diversity of participants enrolled and barriers to enrollment
This will be measured using the patient-related outcomes questionnaires.
Measured: From enrollment to the end of the participant's participation or 4 weeks
Renal function by eGFR
Function will be assessed by collection of creatinine and Cystatin-C
Measured: From enrollment to the end of the participant's participation or 4 weeks
Liver function
This will be measured by liver enzymes and complete blood count (CBC); APRI and EMR data for liver imaging
Measured: From enrollment to the end of the participant's participation or 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start18 Sep 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (108)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837181
- Sponsor's protocol ID
- SPeCTRuM
- Other IDs
- 007365A124
- Acronym
- SPeCTRuM
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agbaje AO, Barker AR, Tuomainen TP. Differing Relations Of Arterial Stiffness And Carotid Intima-Media Thickness In Adolescence With Metabolic Risks In Young Adulthood: The ALSPAC Study. Circulation. 2021;144(Suppl_1):A13236-A. doi: doi:10.1161/circ.144.suppl_1.13236
Kelly A, Magge SN, Walega R, Cochrane C, Pipan ME, Zemel BS, Cohen MS, Gidding SS, Townsend R. Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome. J Pediatr. 2019 Sep;212:79-86.e1. doi: 10.1016/j.jpeds.2019.04.059. Epub 2019 Jun 11.
PubMed 31201031DeLoach SS, Townsend RR. Vascular stiffness: its measurement and significance for epidemiologic and outcome studies. Clin J Am Soc Nephrol. 2008 Jan;3(1):184-92. doi: 10.2215/CJN.03340807.
PubMed 18178784Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994 Nov;17(11):1281-9. doi: 10.2337/diacare.17.11.1281.
PubMed 7821168Bergman M, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Apr;210:111636. doi: 10.1016/j.diabres.2024.111636. Epub 2024 Mar 25. No abstract available.
PubMed 38537890Bergman M, Manco M, Satman I, Chan J, Schmidt MI, Sesti G, Vanessa Fiorentino T, Abdul-Ghani M, Jagannathan R, Kumar Thyparambil Aravindakshan P, Gabriel R, Mohan V, Buysschaert M, Bennakhi A, Pascal Kengne A, Dorcely B, Nilsson PM, Tuomi T, Battelino T, Hussain A, Ceriello A, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Mar;209:111589. doi: 10.1016/j.diabres.2024.111589. Epub 2024 Mar 7.
PubMed 38458916McGarry M. Transparency and diversity in cystic fibrosis research. Lancet. 2020 Aug 29;396(10251):601. doi: 10.1016/S0140-6736(20)30906-5. No abstract available.
PubMed 32861304Kartal Ozturk G, Conkar S, Eski A, Gulen F, Keskinoglu A, Demir E. Evaluation of increased arterial stiffness in pediatric patients with cystic fibrosis by augmentation index and pulse wave velocity analysis. Pediatr Pulmonol. 2020 May;55(5):1147-1153. doi: 10.1002/ppul.24688. Epub 2020 Feb 14.
PubMed 32057197Eising JB, van der Ent CK, Teske AJ, Vanderschuren MM, Uiterwaal CSPM, Meijboom FJ. Young patients with cystic fibrosis demonstrate subtle alterations of the cardiovascular system. J Cyst Fibros. 2018 Sep;17(5):643-649. doi: 10.1016/j.jcf.2017.12.009. Epub 2018 Feb 3.
PubMed 29398489Buehler T, Steinmann M, Singer F, Regamey N, Casaulta C, Schoeni MH, Simonetti GD. Increased arterial stiffness in children with cystic fibrosis. Eur Respir J. 2012 Jun;39(6):1536-7. doi: 10.1183/09031936.00212511. No abstract available.
PubMed 22654008Urbina EM, Isom S, Bell RA, Bowlby DA, D'Agostino R Jr, Daniels SR, Dolan LM, Imperatore G, Marcovina SM, Merchant AT, Reynolds K, Shah AS, Wadwa RP, Dabelea D; SEARCH for Diabetes in Youth Study Group. Burden of Cardiovascular Risk Factors Over Time and Arterial Stiffness in Youth With Type 1 Diabetes Mellitus: The SEARCH for Diabetes in Youth Study. J Am Heart Assoc. 2019 Jul 2;8(13):e010150. doi: 10.1161/JAHA.118.010150. Epub 2019 Jun 19.
PubMed 31213111Stoner L, Kucharska-Newton A, Meyer ML. Cardiometabolic Health and Carotid-Femoral Pulse Wave Velocity in Children: A Systematic Review and Meta-Regression. J Pediatr. 2020 Mar;218:98-105.e3. doi: 10.1016/j.jpeds.2019.10.065. Epub 2019 Dec 4.
PubMed 31810627Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.
PubMed 20530030Mendizabal B, Urbina EM. Subclinical Atherosclerosis in Youth: Relation to Obesity, Insulin Resistance, and Polycystic Ovary Syndrome. J Pediatr. 2017 Nov;190:14-20. doi: 10.1016/j.jpeds.2017.06.043. Epub 2017 Jul 13. No abstract available.
PubMed 28712518Khoury M, Urbina EM. Hypertension in adolescents: diagnosis, treatment, and implications. Lancet Child Adolesc Health. 2021 May;5(5):357-366. doi: 10.1016/S2352-4642(20)30344-8. Epub 2021 Mar 10.
PubMed 33711291
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
- ClinicalTrials.gov ID
- NCT06837181
- Acronym / sponsor ID
- SPeCTRuM / SPeCTRuM
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, Retinopathy, Neuropathy, Nephropathy
- Keywords
- Cystic Fibrosis, CFRD, Cystic Fibrosis-Related Diabetes, Observational, Physical Activity Tracker, Continuous glucose monitoring, CGM, Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Cystic Fibrosis-Related Diabetes | – | Other: observational studyIndividuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with CFRD diagnosis ≥ 5 years at time of enrollment
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyThis is an observational study. | Other | Individuals with Cystic Fibrosis-Related Diabetes |
Primary outcome
Microvascular Complications
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.
Macrovascular Surrogates
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.
18 secondary outcomes
PhenX English Proficiency
Time frame: From enrollment to the end of the participant's participation or 4 weeks
PhenX Food Security & Prescription Accessibility
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Exercise and Substance Use
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Pubertal Self-Assessment
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Beverage Questionnaire (BEVQ15)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
CFRD Care & Technology
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Diabetes Management Experience
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes (PAID)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes Parents of Teens (P-PAID-T)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Child)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Parent)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry)
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Gold Score
Time frame: From enrollment to the end of the participant's participation or 4 weeks
All of Us
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Continuous glucose monitoring (CGM)-defined glycemic control (time-in-range, time-above-range, time-below-range, glucose variability), and the relationships between CGM metrics and HbA1c, in a diverse population of people with established CFRD
Time frame: 3-10 days
Diversity of participants enrolled and barriers to enrollment
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Renal function by eGFR
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Liver function
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- BackgroundAgbaje AO, Barker AR, Tuomainen TP. Differing Relations Of Arterial Stiffness And Carotid Intima-Media Thickness In Adolescence With Metabolic Risks In Young Adulthood: The ALSPAC Study. Circulation. 2021;144(Suppl_1):A13236-A. doi: doi:10.1161/circ.144.suppl_1.13236
- Background: PubMed 31201031Kelly A, Magge SN, Walega R, Cochrane C, Pipan ME, Zemel BS, Cohen MS, Gidding SS, Townsend R. Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome. J Pediatr. 2019 Sep;212:79-86.e1. doi: 10.1016/j.jpeds.2019.04.059. Epub 2019 Jun 11.
- Background: PubMed 18178784DeLoach SS, Townsend RR. Vascular stiffness: its measurement and significance for epidemiologic and outcome studies. Clin J Am Soc Nephrol. 2008 Jan;3(1):184-92. doi: 10.2215/CJN.03340807.
- Background: PubMed 7821168Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994 Nov;17(11):1281-9. doi: 10.2337/diacare.17.11.1281.
- Background: PubMed 38537890Bergman M, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Apr;210:111636. doi: 10.1016/j.diabres.2024.111636. Epub 2024 Mar 25. No abstract available.
- Background: PubMed 38458916Bergman M, Manco M, Satman I, Chan J, Schmidt MI, Sesti G, Vanessa Fiorentino T, Abdul-Ghani M, Jagannathan R, Kumar Thyparambil Aravindakshan P, Gabriel R, Mohan V, Buysschaert M, Bennakhi A, Pascal Kengne A, Dorcely B, Nilsson PM, Tuomi T, Battelino T, Hussain A, Ceriello A, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Mar;209:111589. doi: 10.1016/j.diabres.2024.111589. Epub 2024 Mar 7.
- Background: PubMed 32861304McGarry M. Transparency and diversity in cystic fibrosis research. Lancet. 2020 Aug 29;396(10251):601. doi: 10.1016/S0140-6736(20)30906-5. No abstract available.
- Background: PubMed 32057197Kartal Ozturk G, Conkar S, Eski A, Gulen F, Keskinoglu A, Demir E. Evaluation of increased arterial stiffness in pediatric patients with cystic fibrosis by augmentation index and pulse wave velocity analysis. Pediatr Pulmonol. 2020 May;55(5):1147-1153. doi: 10.1002/ppul.24688. Epub 2020 Feb 14.
- Background: PubMed 29398489Eising JB, van der Ent CK, Teske AJ, Vanderschuren MM, Uiterwaal CSPM, Meijboom FJ. Young patients with cystic fibrosis demonstrate subtle alterations of the cardiovascular system. J Cyst Fibros. 2018 Sep;17(5):643-649. doi: 10.1016/j.jcf.2017.12.009. Epub 2018 Feb 3.
- Background: PubMed 22654008Buehler T, Steinmann M, Singer F, Regamey N, Casaulta C, Schoeni MH, Simonetti GD. Increased arterial stiffness in children with cystic fibrosis. Eur Respir J. 2012 Jun;39(6):1536-7. doi: 10.1183/09031936.00212511. No abstract available.
- Background: PubMed 31213111Urbina EM, Isom S, Bell RA, Bowlby DA, D'Agostino R Jr, Daniels SR, Dolan LM, Imperatore G, Marcovina SM, Merchant AT, Reynolds K, Shah AS, Wadwa RP, Dabelea D; SEARCH for Diabetes in Youth Study Group. Burden of Cardiovascular Risk Factors Over Time and Arterial Stiffness in Youth With Type 1 Diabetes Mellitus: The SEARCH for Diabetes in Youth Study. J Am Heart Assoc. 2019 Jul 2;8(13):e010150. doi: 10.1161/JAHA.118.010150. Epub 2019 Jun 19.
- Background: PubMed 31810627Stoner L, Kucharska-Newton A, Meyer ML. Cardiometabolic Health and Carotid-Femoral Pulse Wave Velocity in Children: A Systematic Review and Meta-Regression. J Pediatr. 2020 Mar;218:98-105.e3. doi: 10.1016/j.jpeds.2019.10.065. Epub 2019 Dec 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis (CF) and Cystic Fibrosis-related Diabetes, run by Jaeb Center for Health Research at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy Sibayan, MPH, CCRP (813-975-8690, jsibayan@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Complications (time frame: From enrollment to the end of the participant's participation or 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837181, which also lists 108 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.