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Behavioural Intervention

NSSB+ HI- GI 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Investigator Fidelity

Participant Fidelity

+4 more

Secondary outcome measures

Change in incremental glucose AUC

Change in plasma Cysteine (Cys)

Change in plasma Cystine (CySS)

+12 more

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Emory UniversityLead Sponsor

1,641 Previous Clinical Trials

2,561,862 Total Patients Enrolled

20 Trials studying Cystic Fibrosis

1,906 Patients Enrolled for Cystic Fibrosis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,361 Previous Clinical Trials

4,314,860 Total Patients Enrolled

26 Trials studying Cystic Fibrosis

14,357 Patients Enrolled for Cystic Fibrosis

Tanicia Daley, MD, MPHPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study currently open and accepting participants?

"According to information available on clinicaltrials.gov, this study is actively seeking participants. Initially shared on 3/22/2024, the trial was most recently revised on 4/4/2024."

Answered by AI

What is the total number of participants enrolled in this clinical investigation?

"Indeed, the clinicaltrials.gov record shows that this investigation is actively enrolling volunteers. The trial was initially published on March 22nd, 2024 and recently revised on April 4th, 2024. It seeks to recruit a total of 40 participants from one designated site."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The main focus of this medical investigation, spanning a 2-year period, is the Recruitment Rate. Secondary endpoints entail variations in incremental glucose AUC over 120 minutes from baseline, computation of the Disposition Index reflecting beta cell function relative to insulin resistance level through (WBISI) × (insulin secretion), and evaluation of Whole-body Insulin Sensitivity Index using Matsuda and Defronzo's technique encompassing both hepatic and peripheral tissue insulin sensitivity. HOMA-IR will serve as an indicator of hepatic insulin resistance."

Answered by AI

Are individuals above the age of 80 eligible to participate in this medical trial?

"Individuals aged between 12 and 21 are eligible to participate in this research study according to the inclusion criteria. Among the available clinical trials, there are specifically 79 studies catering to individuals under 18 years old and 359 trials oriented towards those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Tanicia Daley 2024. "A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06350149.

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