Last reviewed · How we verify
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: * Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. * What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.
Details
| Lead sponsor | Emory University |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 40 |
| Start date | 2024-03-22 |
| Completion | 2025-09 |
Conditions
- Cystic Fibrosis
Interventions
- Sugar Sweetened Beverages (SSB)
- Hi GI
- Lo GI
Primary outcomes
- Recruitment Rate — 2 years
Recruitment rate of participants. Goal is to recruit 3 participants per month. - Refusal Rate — 2 years
Refusal rates for participation. 20%of screened participants will refuse to participate - Investigator Fidelity — 2 years
Capacity of the research team to manage the intervention. Goal is \>85%. - Participant Fidelity — 2 years
Feasibility of data collection, including primary and secondary outcome measures. Goal is \>85% - Acceptability — 2 years
Acceptability and burden of intervention on participants. Likert scale response of \>3(out of 5) on post study evaluation that study is not burdensome and acceptable - Retention Rates — 2 years
Retention rates as the participants complete the intervention. Goal is \>80%
Countries
United States