Study Summary
This trialwill test if a low glycemic diet is safe and helpful for adults with CF, looking at changes in weight, body composition and glucose levels.
Eligible Conditions
- Diabetes-Related Cystic Fibrosis
- Cystic Fibrosis with Intestinal Manifestations
- Cystic Fibrosis
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
3 Primary · 19 Secondary · Reporting Duration: Baseline to 10 weeks
Baseline and 10 weeks
Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score
Change in Modified Activity Questionnaire (MAQ) score
Change in Patient Assessment of Constipation (PAC) questionnaire score
Change in Patient Assessment of Gastrointestinal Symptom (PAGI-SYM) questionnaire score
Change in c-reactive protein (CRP)
Change in erythrocyte sedimentation rate (ESR)
Change in intestinal fatty acid binding protein (I-FABP)
Change in lean and fat mass
Change in percent time <54 mg/dL
Change in weight from baseline and 10 weeks
Number of episodes of symptomatic hypoglycemia
Baseline to 10 weeks
Change in CGM average glucose
Change in CGM coefficient of variation (CV)
Change in CGM glucose management indicator (GMI)
Change in CGM standard deviation (SD)
Change in percent time 70-180 mg/dL on CGM
Change in percent time >140 mg/dL
Change in percent time greater than 180 mg/dL on CGM
Change in percent time greater than >250 mg/dL on CGM
Change in percent time less than 50 mg/dL on CGM
Change in percent time less than 70 mg/dL on CGM
Week 10
Patient reported tolerability of dietary intervention, Likert scale
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Low Glycemic Load Diet
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Low Glycemic Load Diet · No Placebo Group · N/A
Low Glycemic Load Diet
Behavioral
Experimental Group · 1 Intervention: Low Glycemic Load Diet · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Glycemic Load Diet
2014
N/A
~190
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 10 weeks
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
726 Previous Clinical Trials
5,432,042 Total Patients Enrolled
16 Trials studying Cystic Fibrosis
1,665 Patients Enrolled for Cystic Fibrosis
Melissa S Putman, MD,MSPrincipal InvestigatorBoston Children's Hospital; Massachusetts General Hospital
Eligibility Criteria
Age 18 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) is between 21 and 25 kilograms per square meter.
References
- 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. Epub 2006 Jul 17.
- 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.
- Moran, Antoinette, Carol Brunzell, Richard C. Cohen, Marcia Katz, Bruce C. Marshall, Gary Onady, Karen A. Robinson, et al.. 2010. “Clinical Care Guidelines for Cystic Fibrosis–related Diabetes”. Diabetes Care. American Diabetes Association. doi:10.2337/dc10-1768.
- 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. Review.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- Melissa Putman 2021. "A Pilot Study of a Low Glycemic Load Diet in Adults With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04519853.