Actively Recruiting
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
147 weeks
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 study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.
CONDITIONS
Official Title
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Who Can Participate
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 defined by at least one of: recent oral glucose tolerance test with 2-hour glucose >200 mg/dL within 2 years, HbA1c >6.5% within 2 years, or current insulin use
You will not qualify if you...
- Lung function below 50% predicted on recent pulmonary testing
- Body mass index under 18 kg/m2
- Receiving enteral nutrition support through gastrostomy tube feeds
- Pregnant, planning pregnancy within 3 months, or sexually active without contraception
- Use of intravenous antibiotics or systemic high-dose steroids for cystic fibrosis flare within last month
- Started or stopped cystic fibrosis modulator treatment within 3 months prior to joining
- Currently following a low glycemic load or carbohydrate-restricted diet with less than 30% daily calories from carbohydrates
AI-Screening
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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
Research Team
K
Kevin J Scully, MB BCh BAO
CONTACT
M
Melissa S Putman, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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