Weight Trajectory with ETI

Weight Trajectory with ETI

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Description
Use of elexacaftor-texacaftor-ivacaftor ("ETI"), also known as Trikafta, is associated with weight gain in most people with cystic fibrosis (CF) who take this medication. However, some people gain more or less weight than is expected, and this can be either beneficial or problematic based on the individual's starting weight. The goal of this study is to compare factors between children and young adults with CF who have either had robust or minimal weight gain after one year of treatment with ETI. This observational study requires one study visit to CHOP that will last approximately 6 hours. 

Eligibility and criteria
IRB Number:
22-020088
Eligible age range:
7 years - 26 years
Clinical trial phase:
N/A
Official title:
Factors Associated with Robust or Minimal Weight Gain After Elexacaftor-Tezacaftor-Ivacaftor

What to expect
You will be asked to come to CHOP for one study visit that will last about 6 hours. After the study visit is complete, you will be asked to answer three phone calls at home, during which you will be interviewed about what you ate during the previous 24 hours. After these phone calls, your active participation in the study will be complete. The study team will continue to review your clinical information (i.e., medical record) for about 1 year after your study visit.
The 6-hour study visit will involve the following procedures:
  • Overnight fast the night before the study visit
  • Physical exam
  • Whole body X-ray imaging (DXA scan)
  • Resting Energy Expenditure - measurement of energy use (by looking at amount of oxygen and carbon dioxide in the air one breathes)
  • Body Surface Gastric Mapping (BSGM) - measurement of stomach muscle activity (by wearing a sticker)
  • Stool sample collection
  • Questionnaires

Related specialties
Smiling CHOP patient holding shopping bag

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