protocolSection identificationModule nctId: NCT06350149, orgStudyIdInfo id: STUDY00004637, secondaryIdInfos id: 1R21DK128731-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21DK128731-01A1, briefTitle: A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: 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 CFParticipants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Sugar Sweetened Beverages (SSB), interventions name: Hi GI, interventions name: Lo GI, outcomesModule primaryOutcomes measure: Recruitment Rate, primaryOutcomes measure: Refusal Rate, primaryOutcomes measure: Investigator Fidelity, primaryOutcomes measure: Participant Fidelity, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Retention Rates, primaryOutcomes measure: Recruitment, secondaryOutcomes measure: Change in plasma Cysteine (Cys), secondaryOutcomes measure: Change in plasma Cystine (CySS), secondaryOutcomes measure: Change in plasma Glutathione (GSH), secondaryOutcomes measure: Change in plasma Glutathione Disulfide (GSSG), secondaryOutcomes measure: Change in redox potentials (EhCys/ CySS and EhGSH/GSSG), secondaryOutcomes measure: Insulinogenic index, secondaryOutcomes measure: Whole body insulin sensitivity index (WBISI-Matsuda), secondaryOutcomes measure: Disposition Index, secondaryOutcomes measure: Change in plasma Eh Cys/CySS, secondaryOutcomes measure: Change in incremental glucose AUC, secondaryOutcomes measure: Changes in Plasma insulin, secondaryOutcomes measure: Changes in Plasma C-peptide, secondaryOutcomes measure: Changes in Plasma Glucagon, secondaryOutcomes measure: Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1), secondaryOutcomes measure: Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Center for Advanced Pediatrics: Emory Healthcare, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30329, country: United States, contacts name: Tanicia Daley, MD, role: CONTACT, phone: 404-785-5437, email: tanicia.daley@emory.edu, contacts name: Arlene Stecenko, MD, role: CONTACT, phone: 404-727-1460, email: astecen@emory.edu, contacts name: Tanicia Daley, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jessica Alvarez, PhD, role: SUB_INVESTIGATOR, contacts name: Arlene Stecenko, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False