Genetics of Insulin and Incretins in Cystic Fibrosis
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorChildren's Hospital of Philadelphia
About this trial
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
This trial does not accept healthy volunteersQualifiers
Subjects age >2y
Diagnosis of Cystic Fibrosis
For subjects< 18 years, parental/guardian permission (informed consent) and if appropriate, child assent
Disqualifiers
Established diagnosis of non-CFRD (cystic fibrosis related diabetes) (e.g T1DM)
Trial population
Patients with Cystic Fibrosis age \>2 yrs
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood or Saliva Sample Collection
GeneticA blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.
Treatment groups
550 Participants
are divided into 1 treatment groupGroup A: Patients with Cystic Fibrosis1 intervention
Trial outcomes
Primary outcomes
1
Blood sample for DNA to genotype TCF7L2 and about 10 other GWAS-implicated T2DM genes.
To examine the prevalence of GWAS-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in children and adults with CF.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov