The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Recruiting now · Not applicable
Conditions studied: Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations
In brief
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.
Key facts
- Study ID
- NCT05723445
- Run by
- Rhode Island Hospital
- People needed
- 15
- Starts
- 2023-09-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years and above
- Genetically confirmed diagnosis of CF
- Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
- Criteria for CFRD:
- A.) Most recent OGTT 2-hour glucose >200 mg/dL within the past two years, and/or; B.) HbA1c >6.5% in the past two years, and/or; C.) Current use of insulin
You may not qualify if…
- FEV1 <50% predicted on most recent pulmonary function testing
- BMI <18 kg/m2
- Currently receiving enteral nutrition support via GT feeds
- Pregnancy, plan to become pregnant in the next 3-months, or sexually active without use of contraception
- Use of IV antibiotics or systemic supraphysiologic glucocorticoids for CF exacerbation within 1 month
- Started or stopped treatment with a CFTR modulator within 3 months of enrollment
- Currently adhering to an LGL or other carbohydrate-restricted diet (carbohydrate intake <30% of total daily caloric intake)
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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