Effects of a Low Glycemic Load Diet on Diabetes and Body Composition in Adults with Cystic Fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of a low glycemic load (LGL) diet on dysglycemia, insulin needs, body composition, gastrointestinal symptoms, and quality of life in adults with cystic fibrosis-related diabetes (CFRD). Participants will use continuous glucose monitors (CGM) to assess the diet's effects in both controlled settings and free-living conditions. The study aims to provide data on dietary interventions for managing CFRD, which is crucial as patients with cystic fibrosis live longer and face increased risks of metabolic diseases. By understanding the dietary composition's effects, the study seeks to improve health outcomes for this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Kevin J Scully, MB BCh BAO — Rhode Island Hospital
• Study coordinator: Kevin J Scully, MB BCh BAO
• Email: kevin_scully@brown.edu
• Phone: 401-444-5504

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.