Clinical trial
Evaluation of the Enteroinsular Axis in Cystic Fibrosis
Name
12-009589
Description
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.
Trial arms
Trial start
2013-05-01
Estimated PCD
2025-07-01
Trial end
2025-07-01
Status
Recruiting
Treatment
Blood or Saliva Sample Collection
A blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.
Arms:
Patients with Cystic Fibrosis
Size
550
Primary endpoint
Blood sample for DNA to genotype TCF7L2 and about 10 other GWAS-implicated T2DM genes.
1 day
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)
.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 550, 'type': 'ESTIMATED'}}
Updated at
2023-08-14
1 organization
1 product
1 indication
Organization
Children's Hospital of PhiladelphiaIndication
Cystic Fibrosis