Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05723445

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

Led by Rhode Island Hospital · Updated on 2025-08-22

15

Participants Needed

2

Research Sites

147 weeks

Total Duration

On this page

Sponsors

R

Rhode Island Hospital

Lead Sponsor

C

Cystic Fibrosis Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and above
  • Genetically confirmed diagnosis of cystic fibrosis
  • Diagnosis of pancreatic insufficiency requiring pancreatic enzyme replacement
  • Diagnosis of cystic fibrosis-related diabetes defined by at least one of: recent oral glucose tolerance test with 2-hour glucose >200 mg/dL within 2 years, HbA1c >6.5% within 2 years, or current insulin use
Not Eligible

You will not qualify if you...

  • Lung function below 50% predicted on recent pulmonary testing
  • Body mass index under 18 kg/m2
  • Receiving enteral nutrition support through gastrostomy tube feeds
  • Pregnant, planning pregnancy within 3 months, or sexually active without contraception
  • Use of intravenous antibiotics or systemic high-dose steroids for cystic fibrosis flare within last month
  • Started or stopped cystic fibrosis modulator treatment within 3 months prior to joining
  • Currently following a low glycemic load or carbohydrate-restricted diet with less than 30% daily calories from carbohydrates

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

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Research Team

K

Kevin J Scully, MB BCh BAO

CONTACT

M

Melissa S Putman, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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