Genetics of Insulin and Incretins in Cystic Fibrosis

RECRUITING

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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.

Conditions:

🦠 Cystic Fibrosis

🗓️ Study Start (Actual) May 2013

🗓️ Primary Completion (Estimated) July 2025

✅ Study Completion (Estimated) July 2025

👥 Enrollment (Estimated) 550

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

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)
.

Ages Eligible for Study: 2 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 9 May 2013
First Submitted that Met QC Criteria 9 May 2013
First Posted 13 May 2013

Study Record Updates