Genetics of Insulin and Incretins in Cystic Fibrosis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT01852448
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood or Saliva Sample Collection — GENETIC
    A blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.

Study Details

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.

Key Dates

Start date
May 31, 2013
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Patients with Cystic Fibrosis
    Blood or saliva sample collection and medical record review.

Primary Outcome Measure

Blood sample for DNA to genotype TCF7L2 and about 10 other GWAS-implicated T2DM genes. [ Time Frame: 1 day ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Children's Hopsital of PhiladelphiaPhiladelphiaPennsylvania19104
Rachel Walega
[email protected]
267-586-5969
Andrea Kelly, MD (PRINCIPAL_INVESTIGATOR)
The University of PennsylvaniaPhiladelphiaPennsylvania19104
Rachel Walega
[email protected]
267-586-5969
Michael Rickels, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Children's Hopsital of Philadelphia· Philadelphia, PAThe University of Pennsylvania· Philadelphia, PA

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