The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes

NCT05723445 | Recruiting

• 1 other identifier: 1943156-3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Cystic Fibrosis-Related Diabetes; Low Glycemic Load; Continuous Glucose Monitoring; Body Composition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Change in CGM average glucose (AG) mg/dL

  Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

• Change in percent time >180 mg/dL

  Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

• Change in percent time >250 mg/dL

  Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

• Change in CGM standard deviation (SD)

  Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

• Change in CGM coefficient of variation (CV)

  Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

Study Arms (1)

Low Glycemic Load Diet

EXPERIMENTAL

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

Behavioral: Low Glycemic Load Diet

Interventions

Low Glycemic Load Diet BEHAVIORAL

Food delivery service will provide a low glycemic load diet for 8 weeks, followed by a 4-month period of self-adherence to a low glycemic load diet with close nutritionist follow up

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:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (21)

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  PMID: 24170579 BACKGROUND

• 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.

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• Gaskin KJ. Nutritional care in children with cystic fibrosis: are our patients becoming better? Eur J Clin Nutr. 2013 May;67(5):558-64. doi: 10.1038/ejcn.2013.20. Epub 2013 Mar 6.

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• Thomas D, Elliott EJ. Low glycaemic index, or low glycaemic load, diets for diabetes mellitus. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006296. doi: 10.1002/14651858.CD006296.pub2.

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• Scully KJ, Sherwood JS, Martin K, Ruazol M, Marchetti P, Larkin M, Zheng H, Sawicki GS, Uluer A, Neuringer I, Yonker LM, Sicilian L, Wexler DJ, Putman MS. Continuous Glucose Monitoring and HbA1c in Cystic Fibrosis: Clinical Correlations and Implications for CFRD Diagnosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1444-e1454. doi: 10.1210/clinem/dgab857.

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• Scully KJ, Jay LT, Freedman S, Sawicki GS, Uluer A, Finkelstein JS, Putman MS. The Relationship between Body Composition, Dietary Intake, Physical Activity, and Pulmonary Status in Adolescents and Adults with Cystic Fibrosis. Nutrients. 2022 Jan 12;14(2):310. doi: 10.3390/nu14020310.

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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

• Kevin J Scully, MB BCh BAO

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Melissa S Putman, MD, MSc

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin J Scully, MB BCh BAO

CONTACT

401-444-5504; kevin_scully@brown.edu

Melissa S Putman, MD, MSc

CONTACT

617-355-7476; melissa.putman@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single dietary treatment with a meal-delivery phase and free-living conditions phase, as well as a run-in period as a control

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 10, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)