Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome.
Andrea Kelly, Sheela N Magge, Rachel Walega...
https://pubmed.ncbi.nlm.nih.gov/31201031Actively Recruiting
Age: 12Years +
All Genders
ID06837181
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Led by Jaeb Center for Health Research · Updated on 2026-02-10
200
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter observational study to understand the prevalence of diabetes-related complications in adolescents and adults with cystic fibrosis-related diabetes (CFRD). The study focuses on both microvascular complications and macrovascular surrogates in people who have had a CFRD diagnosis for more than five years. This research aims to provide a clearer picture of these complications in a diverse population with established CFRD. Participants diagnosed with CFRD for over five years will be included in the study. The study does not involve any treatment but observes participants to collect data on their condition. The primary outcomes focus on identifying microvascular complications and macrovascular surrogates within approximately four weeks of participation. Secondary outcomes include various assessments such as glucose control through continuous glucose monitoring, liver and kidney function, and other health and lifestyle questionnaires. During the study, participants will complete multiple questionnaires related to their diabetes management, food security, exercise, and fears related to hypoglycemia. Researchers will also assess blood glucose patterns using continuous glucose monitoring for 3 to 10 days. Additional monitoring includes renal and liver function tests and evaluation of cardiovascular risk factors. Participants’ data will be collected during their enrollment and up to about four weeks, helping researchers better understand CFRD complications and related health factors in this population.
CONDITIONS
Brief Title
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent (and assent when applicable) from participant or authorized representative
- Adults must be able to consent on their own
- Willing and able to follow study requirements
- Age 12 years or older at enrollment
- Confirmed cystic fibrosis diagnosis by two CF-causing mutations and/or positive sweat test
- Diagnosed with cystic fibrosis-related diabetes for 5 or more years at enrollment
You will not qualify if you...
- Any illness or condition that could affect study results or increase risk
- History of transplant
- Pregnancy at consent or during study participation
- Irregular or controlled irregular heart rhythms
- Carotid or aortic valve narrowing
- Peripheral or leg artery disease
- Generalized constriction or spasm of muscular conduit arteries
- Limb with intravenous access, arterio-venous shunt, or compromised circulation cannot be used for pressure readings
- Pressure readings not allowed on side of body with mastectomy
- Other exclusions may be made by investigator's assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Observational Monitoring
Duration - Up to 4 weeks
Participants with cystic fibrosis-related diabetes are observed to assess various health outcomes and diabetes-related measures.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
Stanford University
Palo Alto, California, United States, 94304
Not Yet Recruiting
4
University of California San Diego
San Diego, California, United States, 92103
Not Yet Recruiting
5
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
7
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
9
Tulane University
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
10
Massachusetts
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
11
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Not Yet Recruiting
13
Columbia University Cystic Fibrosis Program
New York, New York, United States, 10032
Not Yet Recruiting
14
Atrium Health Wake Forest Baptist (Wake Forest Baptist)
Winston-Salem, North Carolina, United States, 27104
Not Yet Recruiting
15
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Actively Recruiting
16
Medical University of South Carolina
Charlestone, South Carolina, United States, 29425
Not Yet Recruiting
17
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
18
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
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Research Team
J
Judy Sibayan, MPH, CCRP
H
Haley Fonseca, PhD, RDN, LDN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Elaine M Urbina, Scott Isom, Ronny A Bell...
https://pubmed.ncbi.nlm.nih.gov/31213111