Low Glycemic Load Diet for Cystic Fibrosis-Related Diabetes

This study is looking at how a low glycemic load (LGL) diet affects adults with cystic fibrosis-related diabetes (CFRD). The LGL diet aims to help manage blood sugar levels and improve body composition. For 8 weeks, you would receive meals from a food delivery service that follow the LGL diet. After that, you would follow the LGL diet on your own for 4 months with support from a nutritionist. Researchers will use continuous glucose monitors (CGM) to see how your blood sugar levels change. They will also look at your insulin needs, body composition (how much fat and muscle you have), and quality of life. You can join if you are 18 to 70 years old, have cystic fibrosis (CF) with pancreatic insufficiency, and meet certain criteria for CFRD, such as a recent high blood sugar test or A1c level. The study aims to see if this diet helps keep your blood sugar in a healthy range.

Study design
This is an interventional study with 15 participants. It tests a low glycemic load diet in a controlled setting and then in everyday life.
What's involved
You would follow a low glycemic load diet for 8 weeks with delivered meals, then for 4 months on your own with nutritionist support. Your blood sugar will be monitored at the start, after 8 weeks, and after 4 months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 4 months after the initial 8-week meal delivery phase to assess long-term effects.

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NCT05723445

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

Recruiting
NAAges 18–70InterventionalTreatment
Rhode Island Hospital
~15 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Low Glycemic Load Diet

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in percent time in target range 70-180 mg/dL
Measured over Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)
Cystic Fibrosis
Cystic Fibrosis-related Diabetes
Cystic Fibrosis With Intestinal Manifestations
2 sites across 2 states
Massachusetts1
Rhode Island1
  • Kevin J Scully, MB BCh BAO · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital
  • Melissa S Putman, MD, MSc · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years and above
Genetically confirmed diagnosis of CF
Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
Criteria for CFRD:

Exclusion

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)
  • Change in percent time in target range 70-180 mg/dLBaseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

    Continuous glucose monitoring