A Pilot Study of a Low Glycemic Load Diet in Adults With Cystic Fibrosis

NCT04519853 | Completed

• 1 other identifier: P00034904
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes; Cystic Fibrosis With Intestinal Manifestations

Keywords

Cystic Fibrosis Related Diabetes; Low Glycemic Load; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (3)

• Change in weight from baseline and 10 weeks

  Anthropometric measure

  Baseline and 10 weeks

• Change in percent time <54 mg/dL

  Continuous glucose monitoring

  Baseline and 10 weeks

• 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 Outcomes (19)

• Change in percent time >140 mg/dL

  Baseline to 10 weeks

• Change in CGM average glucose

  Baseline to 10 weeks

• Change in CGM glucose management indicator (GMI)

  Baseline to 10 weeks

• Change in CGM standard deviation (SD)

  Baseline to 10 weeks

• Change in CGM coefficient of variation (CV)

  Baseline to 10 weeks

Study Arms (1)

Low Glycemic Load Diet

EXPERIMENTAL

Feeding study with dietary composition (approximately) 50% fat, 30% carbohydrate, 20% protein.

Behavioral: Low Glycemic Load Diet

Interventions

Low Glycemic Load Diet BEHAVIORAL

Food delivery service will provide a low glycemic load diet for 8 weeks

Low Glycemic Load Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF
• Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
• 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
• BMI 21-25 kg/m2
• years and above

You may not qualify if:

• Current use of insulin
• Most recent HbA1c ≥6.5%
• History of solid organ transplant or currently listed for solid organ transplant
• FEV1 \<50% predicted on most recent pulmonary function testing
• Currently receiving enteral nutrition support
• Current or anticipated pregnancy in the next 1 year
• Hospitalization for CF exacerbation within 1 month of enrollment
• Started or stopped treatment with Trikafta or other CFTR modulator within 3 months of enrollment
• Currently adhering to a low glycemic index or other carbohydrate restricted diet

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 21115772 BACKGROUND

• 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.

  PMID: 31659728 BACKGROUND

• 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.

  PMID: 31036487 BACKGROUND

• 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.

  PMID: 16844431 BACKGROUND

• 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.

  PMID: 22606371 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Melissa S Putman, MD,MS

  Boston Children's Hospital; Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Attending in Endocrinology

Model Details: Single dietary treatment arm with run-in period as a control

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 20, 2020
• Study Start: October 25, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)