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

Must not have

Currently receiving enteral nutrition support via GT feeds

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I need medication to help my pancreas work.

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I am 18 years old or older.

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My cystic fibrosis diagnosis was confirmed through genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being fed through a tube in my stomach.

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.