NCT05723445 The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
| NCT ID | NCT05723445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-09-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Kevin J Scully, MB BCh BAO
PRINCIPAL INVESTIGATOR
Rhode Island Hospital
Frequently Asked Questions
Who can join the NCT05723445 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05723445 currently recruiting?
Yes, NCT05723445 is actively recruiting participants. Contact the research team at kevin_scully@brown.edu for enrollment information.
Where is the NCT05723445 trial being conducted?
This trial is being conducted at Boston, United States, Providence, United States.
Who is sponsoring the NCT05723445 clinical trial?
NCT05723445 is sponsored by Rhode Island Hospital. The principal investigator is Kevin J Scully, MB BCh BAO at Rhode Island Hospital. The trial plans to enroll 15 participants.