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Study on High vs. Low Glycemic Index Meals in Adolescents and Young Adults with Cystic Fibrosis

This study is looking at how different types of meals affect blood sugar in adolescents and young adults (ages 12-21) with Cystic Fibrosis (CF). Researchers want to understand if eating foods with a high or low glycemic index (how quickly food raises blood sugar) and drinking sugary beverages might play a role in developing Cystic Fibrosis-related diabetes (CFRD). You might be able to join if you have CF, pancreatic insufficiency, and regularly consume added sugars and sugary drinks. The study will assess if this type of research is practical and will look at early changes in blood sugar and how your body produces insulin after these meals. The study aims to enroll 40 participants.

Study design
This is an interventional study, but the phase is not specified. It is designed to evaluate different meal types, including Sugar Sweetened Beverages (SSB), Hi GI (high glycemic index) meals, and Lo GI (low glycemic index) meals.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures recruitment rate, refusal rate, and investigator fidelity at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06350149

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

UNKNOWN
NAAges 12–21Interventional
Emory University
~40 participants
Updated 2024-04-05 on ClinicalTrials.gov
What's tested:Sugar Sweetened Beverages (SSB)Hi GILo GI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Rate
Measured over 2 years
+6 more outcomes measured

Conditions

Cystic Fibrosis

Explore related trials

Cystic FibrosisCFTR Gene

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Tanicia Daley, MD, MPH · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Tanicia Daley, MD, MPH
[email protected]
404-785-5437
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Recruitment Rate2 years

    Recruitment rate of participants. Goal is to recruit 3 participants per month.

  • Refusal Rate2 years

    Refusal rates for participation. 20%of screened participants will refuse to participate

  • Investigator Fidelity2 years

    Capacity of the research team to manage the intervention. Goal is \>85%.

  • Participant Fidelity2 years

    Feasibility of data collection, including primary and secondary outcome measures. Goal is \>85%

  • Acceptability2 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 Rates2 years

    Retention rates as the participants complete the intervention. Goal is \>80%

  • Recruitment2 years

    Length of time it takes to recruit enough participants into the study. Goal is to recruit all patients by the end of second quater of the second year.