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A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis

NCT06350149 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Sugar Sweetened Beverages (SSB)

The following are considered SSBs: non-diet soft drinks/sodas, flavored juice drinks, sweetened tea, energy drinks, and electrolyte replacement drinks.

OTHER

Hi GI

The Glycemic Index of the high-GI meals will be at least 75

OTHER

Lo GI

The Glycemic Index of the low- -GI meals will not be higher than 55.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Tanicia Daley, MD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350149 on ClinicalTrials.gov