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Report for Clinical Trial NCT01852448

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Evaluation of the Enteroinsular Axis in Cystic Fibrosis

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.

NCT01852448 Cystic Fibrosis
MeSH: Cystic Fibrosis Fibrosis

2 Interventions

Name: Blood or Saliva Sample Collection

Description: A blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.

Type: Genetic

Patients with Cystic Fibrosis

Name: Glucose -potentiated arginine (GPA) stimulation tests

Description: Glucose -potentiated arginine (GPA) stimulation tests and mixed meal tolerance tests (MMTT) will be performed on two separate days in the outpatient setting.

Type: Other

Patients with Cystic Fibrosis


Primary Outcomes

Description: To examine the prevalence of GWAS-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in children and adults with CF.

Measure: Blood sample for DNA to genotype TCF7L2 and about 10 other GWAS-implicated T2DM genes.

Time: 1 day

Secondary Outcomes

Description: Pancreatic ß-cell function will be evaluated using the GPA test which can be used to measure β-cell secretory capacity and sensitivity to glucose.

Measure: Glucose-Potentiated Arginine Stimulation Test (GPA test)

Time: 1 day

Other Outcomes

Description: Incretin and insulin secretion as well as glucose tolerance will be assessed using the MMTT.

Measure: Mixed Meal Tolerance Testing (MMTT)

Time: 1 day

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 rs7903146

SECOND PHASE OF STUDY: Inclusion Criteria 1. Subjects age >8y 2. Diagnosis of Cystic Fibrosis 3. pancreatic insufficient 4. negative urine pregnancy test at enrollment 5. TCF7L2 rs7903146 genotype of T/T or C/C 6.



HPO Nodes