|
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
RECRUITINGN/ASponsored by Rhode Island Hospital
Actively Recruiting
PhaseN/A
SponsorRhode Island Hospital
Started2023-09-01
Est. completion2026-07-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05723445
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
Age: 18 Years – 70 YearsHealthy volunteers accepted
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)
Conditions4
Cystic FibrosisCystic Fibrosis With Intestinal ManifestationsCystic Fibrosis-related DiabetesDiabetes
Locations2 sites
Massachusetts
1 siteBoston Children's Hospital
Boston, Massachusetts, 02115
Rhode Island
1 siteRhode Island Hospital
Providence, Rhode Island, 02903
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorRhode Island Hospital
Started2023-09-01
Est. completion2026-07-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05723445