NCT01852448 Genetics of Insulin and Incretins in Cystic Fibrosis
| NCT ID | NCT01852448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2013-05 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2013-05 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes. The mechanisms underlying CFRD development are not fully understood, but recent evidence suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins (gut secreted hormones that augment insulin secretion in response to a nutrient load). This study will examine the prevalence of Genome wide association study (GWAS)-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will use this information to compare incretin and insulin secretion in non-diabetic children and adults with high risk and low risk alleles.
Eligibility Criteria
Inclusion Criteria 1. Subjects age \>2y 2. Diagnosis of Cystic Fibrosis 3. For subjects\< 18 years, parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria 1. Established diagnosis of non-CFRD (cystic fibrosis related diabetes) (e.g T1DM) .
Contact & Investigator
Andrea Kelly, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT01852448 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01852448 currently recruiting?
Yes, NCT01852448 is actively recruiting participants. Contact the research team at walegar1@chop.edu for enrollment information.
Where is the NCT01852448 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT01852448 clinical trial?
NCT01852448 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Andrea Kelly, MD at Children's Hospital of Philadelphia. The trial plans to enroll 550 participants.