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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
Name: Glucose -potentiated arginine (GPA) stimulation tests
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 daySecondary 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 dayOther 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 dayTime 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.