RECRUITING

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

Conditions

Cystic Fibrosis Glycemic Index Cystic Fibrosis Related Diabetes

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-22

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06350149

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.

Ages Eligible for Study:12 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Tanicia Daley, MD, MPH

CONTACT

404-785-5437

tanicia.daley@emory.edu

Jocelyn McNeany

CONTACT

jocelyn.villalobos.mcneany@emory.edu

Principal Investigator

Tanicia Daley, MD, MPH

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Center for Advanced Pediatrics: Emory Healthcare

Atlanta, Georgia, 30329

United States

Collaborators and Investigators

Sponsor: Emory University

Tanicia Daley, MD, MPH, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-22

Study Completion Date2025-09

Study Record Updates

Study Start Date2024-03-22

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Cystic Fibrosis
Glycemic Index
Cystic Fibrosis Related Diabetes

Additional Relevant MeSH Terms

Cystic Fibrosis