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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 belowSelect...
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)
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 moreDINE 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
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
261 Previous Clinical Trials
68,991 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that you have less than 50% of the expected breathing capacity.I have started or stopped a CFTR modulator treatment within the last 3 months.I need medication to help my pancreas work.I am 18 years old or older.I haven't used IV antibiotics or high-dose steroids for cystic fibrosis flare-ups in the last month.I am currently being fed through a tube in my stomach.My cystic fibrosis diagnosis was confirmed through genetic testing.I have diabetes as shown by my glucose test, HbA1c levels, or I'm using insulin.You have a body mass index (BMI) that is less than 18 kg/m2.You are currently following a diet that limits carbohydrates to less than 30% of your daily calorie intake.
Research Study Groups:
This trial has the following groups:- Group 1: Low Glycemic Load Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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