Examining genetics related to insulin and incretins in cystic fibrosis
Evaluation of the Enteroinsular Axis in Cystic Fibrosis
This study is trying to see how certain genes affect insulin and blood sugar levels in people with cystic fibrosis to better understand diabetes related to the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT01852448 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the genetic factors associated with cystic fibrosis related diabetes (CFRD), focusing on the prevalence of specific genetic variants linked to Type 2 Diabetes Mellitus (T2DM). It aims to analyze insulin and incretin secretion in non-diabetic individuals with cystic fibrosis who possess either high-risk or low-risk genetic alleles. By collecting blood or saliva samples from participants aged 2 years and older, the study will assess the relationship between these genetic factors and glucose abnormalities in cystic fibrosis patients. The findings could enhance understanding of CFRD and its implications for patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 2 years and older diagnosed with cystic fibrosis.
Not a fit: Patients with an established diagnosis of non-CFRD, such as Type 1 Diabetes Mellitus, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for cystic fibrosis related diabetes, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown success in exploring genetic factors related to diabetes, but this specific approach in cystic fibrosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) .
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- The Children's Hopsital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- The University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Kelly, MD — Children's Hospital of Philadelphia
- Study coordinator: Rachel Walega
- Email: walegar1@chop.edu
- Phone: 267-586-5969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.