Effects of a Low Glycemic Load Diet on Diabetes and Body Composition in Adults with Cystic Fibrosis
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
NA · Rhode Island Hospital · NCT05723445
This study is testing if a low glycemic load diet can help adults with cystic fibrosis-related diabetes manage their blood sugar and improve their overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05723445 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a genetically confirmed diagnosis of cystic fibrosis and a diagnosis of pancreatic insufficiency requiring enzyme replacement.
Not a fit: Patients with severe lung impairment (FEV1 <50% predicted) or those currently on enteral nutrition support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of diabetes and better overall health outcomes for patients with cystic fibrosis.
How similar studies have performed: While dietary interventions for diabetes have shown success in other populations, this specific approach for cystic fibrosis-related diabetes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations, Cystic Fibrosis-Related Diabetes, Low Glycemic Load, Continuous Glucose Monitoring, Body Composition