← Back to Search

Other

Low Glycemic Load Diet for Cystic Fibrosis and Diabetes (DINE Trial)

N/A

Recruiting

Led By Kevin J Scully, MB BCh BAO

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

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

Must have

Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement

18 years and above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

Awards & highlights

DINE Trial Summary

This trial studies the effect of a low glycemic load diet on adults with cystic fibrosis-related diabetes. It will use glucose monitors to measure the diet in a controlled and free-living setting.

Who is the study for?

Adults with cystic fibrosis-related diabetes (CFRD) who are over 18, have had certain levels of blood glucose or HbA1c in the past two years, use insulin, and require pancreatic enzyme replacement can join. Those pregnant, on specific diets, with severe lung function impairment or recent changes in CF treatments cannot participate.Check my eligibility

What is being tested?

The trial is testing how a low glycemic load diet affects blood sugar control and body composition in adults with CFRD. Participants will be monitored using continuous glucose monitors both during controlled meal delivery and free-living conditions to evaluate the diet's effectiveness.See study design

What are the potential side effects?

While not drug-related, potential side effects may include changes in digestion due to dietary adjustments. Gastrointestinal discomfort could occur as participants adapt to the low glycemic load diet.

DINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need medication to help my pancreas work.

Select...

I am 18 years old or older.

Select...

My cystic fibrosis diagnosis was confirmed through genetic testing.

DINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in percent time in target range 70-180 mg/dL

Secondary outcome measures

Change fat-mass index (FMI, fat mass kg/ height m^2)

Change in Bristol stool chart data

Change in CGM average glucose (AG) mg/dL

+24 more

DINE Trial Design

1Treatment groups

Experimental Treatment

Group I: Low Glycemic Load DietExperimental Treatment1 Intervention

Feeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Glycemic Load Diet

2021

N/A

~200

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,992 Total Patients Enrolled

Cystic Fibrosis FoundationOTHER

189 Previous Clinical Trials

37,195 Total Patients Enrolled

182 Trials studying Cystic Fibrosis

34,258 Patients Enrolled for Cystic Fibrosis

Kevin J Scully, MB BCh BAOPrincipal InvestigatorRhode Island Hospital

Media Library

Low Glycemic Load Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05723445 — N/A

Cystic Fibrosis Research Study Groups: Low Glycemic Load Diet

Cystic Fibrosis Clinical Trial 2023: Low Glycemic Load Diet Highlights & Side Effects. Trial Name: NCT05723445 — N/A

Low Glycemic Load Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05723445 — N/A

Frequently Asked Questions

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

Does this research program accept participants of all ages, including those over 25?

"This trial has set the eligibility bar at 18 years old to 70 years old. There are 264 trials targeting those under 18 and 1233 studies for applicants over 65."

Answered by AI

Is there any availability for individuals to join this clinical experiment?

"As reported on clinicaltrials.gov, this particular study is not currently recruiting patients; it was initially posted in February 1st of 2023 and the most recent update occurred 8 days later. However, there are 1560 other trials that remain open for enrolment at this time."

Answered by AI

What demographics are ideal for participation in this scientific experiment?

"This clinical trial is hoping to enlist up to 15 qualified individuals with cystic fibrosis accompanied by intestinal manifestations. Applicants must range in age from 18-70 and fulfill the following criteria: genetic verification of CF diagnosis, pancreas insufficiency necessitating pancreatic enzyme replacement treatment, OGTT 2-hour glucose above 200 mg/dL within two years or HbA1c over 6.5% during that time frame (or current use of insulin)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes

2023. "The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05723445.

All > Cystic Fibrosis