Cystic Fibrosis Clinical Trial
— DINEOfficial title:
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital | Cystic Fibrosis Foundation |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in percent time in target range 70-180 mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in CGM average glucose (AG) mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in percent time >180 mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in percent time >250 mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in CGM standard deviation (SD) | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in CGM coefficient of variation (CV) | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in percent time <70 mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in percent time <54 mg/dL | Continuous glucose monitoring | Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) | |
Secondary | Change in number of episodes of symptomatic hypoglycemia (average per week) | Weekly emailed survey | Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26)) | |
Secondary | Change in total daily dose of insulin (TDD) | Weekly emailed survey | Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26) | |
Secondary | Change in body mass index (BMI, kg/m2) | Every other week emailed survey | Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26) | |
Secondary | Change in weight (kg) | Every other week emailed survey | Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26) | |
Secondary | Change fat-mass index (FMI, fat mass kg/ height m^2) | DXA body composition measures | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in percent body fat (%) | DXA body composition measures | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in appendicular lean mass index (ALMI, lean mass kg/ height m^2) | DXA body composition measures | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in Patient Assessment of Constipation (PAC) questionnaire score | Likert scale questionnaire with 12 items, each scored 0-4, total score ranging from 0-48 with higher scores related to worse outcomes | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-Sym) questionnaire score | Likert scale questionnaire with 20 items, each scored 0-5, total score ranging from 0-100 with higher scores related to worse outcomes | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score | Likert scale questionnaire with 50 items, each scored 0-4, total score ranging from 0-100 with higher scores reflecting better outcomes | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in Diet Tolerability Questionnaire | Likert scale questionnaire with 5 items, each scored 0-10, total score ranging from 0-50 with higher scores reflecting better diet tolerability | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in Bristol stool chart data | Chart depicting 7 types of stool patterns, ranging from constipation to diarrhea | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in erythrocyte sedimentation rate (ESR) | Laboratory test, measured in mm/hr | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in c-reactive protein (CRP) | Laboratory test, measured in mg/L | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in hemoglobin A1c | Laboratory test, measured in % | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in total cholesterol | Laboratory test, measured in mg/dL | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in high-density lipoprotein (HDL) | Laboratory test, measured in mg/dL | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in low-density lipoprotein (LDL) | Laboratory test, measured in mg/dL | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in triglyceride level | Laboratory test, measured in mg/dL | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) | |
Secondary | Change in intestinal fatty acid binding protein (I-FABP) | Laboratory test, measured in ng/mL | Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26) |
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