Recruiting

Low Glycemic Load Diet

Sponsor:

Rhode Island Hospital

Code:

NCT05723445

Conditions

Cystic Fibrosis

Cystic Fibrosis-related Diabetes

Cystic Fibrosis With Intestinal Manifestations

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Low Glycemic Load Diet

Study Details

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

Study ID

NCT05723445

Start date

Sep 1, 2023

Status verified date

Aug, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Glycemic Load Diet

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

Interventions

Low Glycemic Load Diet

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

Primary outcome measure

  • Change in percent time in target range 70-180 mg/dL [ Time Frame: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months) ]

Central Contacts and Locations

Central contacts

Kevin J Scully, MB BCh BAO

401-444-5504kevin_scully@brown.edu

Melissa S Putman, MD, MSc

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

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Melissa S Putman, MD, MSc

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

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Kevin J Scully, MB BCh BAO

401-444-5504kevin_scully@brown.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-08-22.