Malnutrition in cystic fibrosis: a review.
Suzanne Culhane, Carolyn George, Brittany Pearo...
https://pubmed.ncbi.nlm.nih.gov/24170579Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05723445
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Led by Rhode Island Hospital · Updated on 2025-08-22
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rhode Island Hospital
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a low glycemic load (LGL) diet on blood sugar control, insulin needs, body composition, gastrointestinal symptoms, and quality of life in adults with cystic fibrosis-related diabetes (CFRD). The study is important because current dietary recommendations for cystic fibrosis are based on expert opinion rather than direct evidence, and improving diet quality may help manage diabetes and related complications in this population. Participants will first follow their usual diet for 10 days, then switch to an LGL diet provided by a meal delivery service for 8 weeks. During the meal delivery phase, continuous glucose monitors (CGM) will track blood sugar levels over two 10-day periods. Afterward, participants will continue the LGL diet on their own for 4 months with close support from a nutritionist. The diet consists of about 50% fat, 20% protein, and 30% carbohydrates. Throughout the study, participants will undergo tests including body composition scans (DXA), blood tests, and questionnaires about gastrointestinal symptoms and quality of life at the start, after the meal delivery phase, and at the end of the free-living phase. Researchers will measure changes in glucose control using CGM, insulin use, body fat, and other health markers to understand how the LGL diet affects adults with CFRD over time. Total participation lasts approximately 6 months, including all phases.
CONDITIONS
Brief Title
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years and above
- Genetically confirmed diagnosis of cystic fibrosis
- Diagnosis of pancreatic insufficiency requiring pancreatic enzyme replacement
- Diagnosis of cystic fibrosis-related diabetes based on one or more of: recent oral glucose tolerance test with 2-hour glucose >200 mg/dL, HbA1c >6.5% within past 2 years, or current use of insulin
You will not qualify if you...
- Lung function (FEV1) less than 50% predicted on recent testing
- Body mass index (BMI) less than 18 kg/m2
- Currently receiving enteral nutrition support via gastrostomy tube feeds
- Pregnancy, planning pregnancy within 3 months, or sexually active without contraception
- Use of intravenous antibiotics or high-dose systemic steroids for cystic fibrosis exacerbation within 1 month
- Started or stopped cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatment within 3 months
- Currently following a low glycemic load or other carbohydrate-restricted diet (carbohydrate intake <30% of total daily calories)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Run-in Period
Duration - 10 days
Participants follow their standard diet to establish baseline measures.
1 baseline visit
Treatment
Duration - 8 weeks
Participants receive a low glycemic load diet provided by a meal delivery service while wearing a continuous glucose monitor for two 10-day periods.
Multiple visits including 2 periods of continuous glucose monitoring and assessments at baseline and at the end of the meal delivery phase
Follow-up
Duration - 4 months
Participants adhere to a low glycemic load diet under free-living conditions with close nutritionist follow-up.
Regular nutritionist follow-up visits throughout the period
Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Loading map...
Research Team
K
Kevin J Scully, MB BCh BAO
M
Melissa S Putman, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society.
Antoinette Moran, Carol Brunzell, Richard C Cohen...
https://pubmed.ncbi.nlm.nih.gov/21115772Nutritional care in children with cystic fibrosis: are our patients becoming better?
K J Gaskin
https://pubmed.ncbi.nlm.nih.gov/23462946Low glycaemic index, or low glycaemic load, diets for diabetes mellitus.
Diana Thomas, Elizabeth J Elliott
https://pubmed.ncbi.nlm.nih.gov/19160276Glycemic variability predicts inflammation in adolescents with type 1 diabetes.
Robert P Hoffman, Amanda S Dye, Hong Huang...
https://pubmed.ncbi.nlm.nih.gov/27658133Prevalence of malnutrition and obesity among cystic fibrosis patients.
Paraskevi Panagopoulou, Maria Fotoulaki, Aristidis Nikolaou...
https://pubmed.ncbi.nlm.nih.gov/24003895Longitudinal trends in nutritional status and the relation between lung function and BMI in cystic fibrosis: a population-based cohort study.
Anne L Stephenson, Lisa A Mannik, Shirley Walsh...
https://pubmed.ncbi.nlm.nih.gov/23388659Prevalence and factors associated with overweight and obesity in adults with cystic fibrosis: A single-center analysis.
Tasma Harindhanavudhi, Qi Wang, Jordan Dunitz...
https://pubmed.ncbi.nlm.nih.gov/31727452Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet.
Belinda S Lennerz, Anna Barton, Richard K Bernstein...
https://pubmed.ncbi.nlm.nih.gov/29735574Survival in a bad neighborhood: pancreatic islets in cystic fibrosis.
Andrew W Norris, Katie Larson Ode, Lina Merjaneh...
https://pubmed.ncbi.nlm.nih.gov/30759072