Cystic Fibrosis Clinical Trial
Official title:
A Pilot Study to Test the Safety and Tolerability of a Low Glycemic Load Dietary Intervention in Adults With Cystic Fibrosis
NCT number | NCT04519853 |
Other study ID # | P00034904 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2021 |
Est. completion date | July 1, 2023 |
Verified date | August 2023 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will be placed on changes in weight, body composition, and glycemic measures obtained via continuous glucose monitor (CGM) usage.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of CF 2. Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement 3. Oral glucose tolerance test within the past three years showing impaired glucose tolerance (2-hour glucose =140 mg/dL) or indeterminate glycemia (1-hour glucose =200), HbA1c 5.7-6.4% in the past one year, and/or or documented random glucose =200 in the past one year 4. BMI 21-25 kg/m2 5. 18 years and above Exclusion Criteria: 1. Current use of insulin 2. Most recent HbA1c =6.5% 3. History of solid organ transplant or currently listed for solid organ transplant 4. FEV1 <50% predicted on most recent pulmonary function testing 5. Currently receiving enteral nutrition support 6. Current or anticipated pregnancy in the next 1 year 7. Hospitalization for CF exacerbation within 1 month of enrollment 8. Started or stopped treatment with Trikafta or other CFTR modulator within 3 months of enrollment 9. Currently adhering to a low glycemic index or other carbohydrate restricted diet |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Balzer BW, Graham CL, Craig ME, Selvadurai H, Donaghue KC, Brand-Miller JC, Steinbeck KS. Low glycaemic index dietary interventions in youth with cystic fibrosis: a systematic review and discussion of the clinical implications. Nutrients. 2012 Apr;4(4):286-96. doi: 10.3390/nu4040286. Epub 2012 Apr 18. — View Citation
Brennan AL, Gyi KM, Wood DM, Johnson J, Holliman R, Baines DL, Philips BJ, Geddes DM, Hodson ME, Baker EH. Airway glucose concentrations and effect on growth of respiratory pathogens in cystic fibrosis. J Cyst Fibros. 2007 Apr;6(2):101-9. doi: 10.1016/j.jcf.2006.03.009. Epub 2006 Jul 17. — View Citation
Gabel ME, Galante GJ, Freedman SD. Gastrointestinal and Hepatobiliary Disease in Cystic Fibrosis. Semin Respir Crit Care Med. 2019 Dec;40(6):825-841. doi: 10.1055/s-0039-1697591. Epub 2019 Oct 28. — View Citation
Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available. — View Citation
Prentice BJ, Ooi CY, Strachan RE, Hameed S, Ebrahimkhani S, Waters SA, Verge CF, Widger J. Early glucose abnormalities are associated with pulmonary inflammation in young children with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):869-873. doi: 10.1016/j.jcf.2019.03.010. Epub 2019 Apr 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weight from baseline and 10 weeks | Anthropometric measure | Baseline and 10 weeks | |
Primary | Change in percent time <54 mg/dL | Continuous glucose monitoring | Baseline and 10 weeks | |
Primary | Patient reported tolerability of dietary intervention, Likert scale | Single Likert scale question of overall diet tolerability, ranging from 1 (intolerable) to 10 (completely tolerable) | Single measurement at 10 weeks after diet completion | |
Secondary | Change in percent time >140 mg/dL | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in CGM average glucose | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in CGM glucose management indicator (GMI) | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in CGM standard deviation (SD) | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in CGM coefficient of variation (CV) | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in percent time less than 50 mg/dL on CGM | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in percent time less than 70 mg/dL on CGM | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in percent time 70-180 mg/dL on CGM | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in percent time greater than 180 mg/dL on CGM | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Change in percent time greater than >250 mg/dL on CGM | Continuous glucose monitoring | Baseline to 10 weeks | |
Secondary | Number of episodes of symptomatic hypoglycemia | Survey | Baseline and 10 weeks | |
Secondary | Change in lean and fat mass | DXA body composition measures | Baseline and 10 weeks | |
Secondary | Change in Patient Assessment of Constipation (PAC) questionnaire score | Likert scale questionnaire with 12 items, each item scored 0-4, total score ranging from 0-48 with higher scores related to worse outcomes | Baseline and 10 weeks | |
Secondary | Change in Patient Assessment of Gastrointestinal Symptom (PAGI-SYM) questionnaire score | Likert scale questionnaire with 20 items, each item scored 0-5, total score ranging from 0-100 with higher scores related to worse outcomes | Baseline and 10 weeks | |
Secondary | Change in Modified Activity Questionnaire (MAQ) score | Questionnaire, units of total hours of exercise over past 12 months, no min or max scores, higher value related to better outcome | Baseline and 10 weeks | |
Secondary | Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score | Likert scale questionnaire, 50 items, each scored 0-4, total score ranging from 0-100 with higher value reflecting better outcome | Baseline and 10 weeks | |
Secondary | Change in erythrocyte sedimentation rate (ESR) | Laboratory test, measured in mm/hr | Baseline and 10 weeks | |
Secondary | Change in c-reactive protein (CRP) | Laboratory test, measured in mg/L | Baseline and 10 weeks | |
Secondary | Change in intestinal fatty acid binding protein (I-FABP) | Laboratory test, measured in ng/mL | Baseline and 10 weeks |
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