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The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes

RecruitingNAAges 18 Years - 70 YearsAllRhode Island Hospital
NCT05723445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Low Glycemic Load Diet
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Where

2 sites
Boston Children's Hospital
Boston, United States
Rhode Island Hospital
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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