High vs Low Glycemic Index Meals for Cystic Fibrosis

N/A

Recruiting

Led By Tanicia Daley, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how consuming excess simple sugars affects the development of diabetes in people with Cystic fibrosis. They will give participants different meals and drinks to see how it affects their blood sugar

Who is the study for?

This study is for adolescents and young adults with Cystic Fibrosis. It's designed to see if different types of sugar in meals affect their blood sugar levels and insulin function. Participants will be given meals with high or low glycemic index sugars, some including sugary drinks.

What is being tested?

The trial tests how the body reacts to meals that have sugars which are absorbed at different rates (high vs low glycemic index) and whether adding a sugary drink makes a difference. Blood samples before and after eating measure changes in glucose, insulin function, and hormones related to digestion.

What are the potential side effects?

Since this trial involves dietary intake rather than medication, side effects may include discomfort from blood draws or potential short-term changes in blood sugar levels due to the meal challenges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Investigator Fidelity

Participant Fidelity

+4 more

Secondary study objectives

Change in incremental glucose AUC

Change in plasma Cysteine (Cys)

Change in plasma Cystine (CySS)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: SSB+ HI- GIExperimental Treatment2 Interventions

All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines

Group II: SSB + LO- GIExperimental Treatment2 Interventions

Group III: NSSB+ LO- GIExperimental Treatment1 Intervention

Group IV: NSSB+ HI- GIExperimental Treatment1 Intervention

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