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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

Description

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

Cystic Fibrosis
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Related Conditions:

Cystic Fibrosis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Atlanta

Center for Advanced Pediatrics: Emory Healthcare, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * English speaking
  • * Diagnosis of CF based on the presence of two known CF causing mutations and/or positive sweat test
  • * Pancreatic insufficiency
  • * Baseline dietary consumption of \>10% total kcal from added sugars and self-reported consumption of \>/= sugar-sweetened beverages per week
  • * Current use or anticipated use of medication that is known to raise or lower blood glucose in the past 4 weeks.
  • * Oral or IV glucocorticoid current or previous use in the past 4 weeks will prohibit enrollment in the study.
  • * Recent pulmonary exacerbation within 3 weeks of enrollment and/or an acute illness requiring a change in antibiotics will also exclude participants.
  • * BMI below the 5th percentile or greater than the 95th percentile for age and sex
  • * FEV1 \<40% or awaiting a lung transplant;
  • * Prior lung or liver transplant or kidney or liver dysfunction.
  • * Use of CFTR modulators is not an exclusion criterion. Rather, for patients recently started on CFTR modulators, we will wait to enroll in the study until on CFTR modulator for at least 2 months.
  • * Diagnosis of CF liver disease.
  • * Uncontrolled exocrine pancreatic insufficiency/malabsorption
  • * Diagnosis of CFRD
  • * G-tube feeds (bolus and/or continuous)
  • * Current enrollment in another intervention study
  • * Changes in diet to lose or gain weight
  • * Gluten allergy or intolerance
  • * Current pregnancy or lactation or plans to become pregnant during study period
  • * History of drug or alcohol abuse
  • * Restrictive dietary patterns (e.g, vegan, ketogenic, intermittent fasting) for more than one month within the last two months prior to screening.
  • * More than 5% body weight change within 2 months of screening visit or Day 1 of mixed meal tolerance test

Ages Eligible for Study

12 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Tanicia Daley, MD, MPH, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2025-09