NCT05723445Recruiting
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Rhode Island Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT05723445
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Sept 2023 to the primary completion date, 1 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving enteral nutrition support via GT feeds
- Started or stopped treatment with a CFTR modulator within 3 months of enrollment
Other
- FEV1 \<50% predicted on most recent pulmonary function testing
- BMI \<18 kg/m2
- 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
- Currently adhering to an LGL or other carbohydrate-restricted diet (carbohydrate intake \<30% of total daily caloric intake)
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.