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Search / Trial NCT05723445

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

Launched by RHODE ISLAND HOSPITAL · Feb 8, 2023

Trial Information

Current as of September 07, 2025

Recruiting

Keywords

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

ClinConnect Summary

This clinical trial is exploring how a low glycemic load (LGL) diet can impact individuals with cystic fibrosis-related diabetes (CFRD). The researchers want to see if this diet can help manage blood sugar levels, reduce insulin needs, and improve body composition, digestive symptoms, and overall quality of life. Participants will use continuous glucose monitors to track their blood sugar while eating meals provided by a delivery service and during their regular daily routines.

To join the study, participants must be 18 years or older, have a confirmed diagnosis of cystic fibrosis, and show signs of diabetes related to their condition. Important criteria include having high blood sugar levels from recent tests or currently using insulin. However, individuals with certain health issues, like severe lung problems or low body weight, or those currently on specific diets will not be eligible. Participants can expect to follow the LGL diet while being closely monitored, and they may benefit from tailored nutritional support throughout the study.

Gender

ALL

Eligibility criteria

  • 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)

About Rhode Island Hospital

Rhode Island Hospital, a leading academic medical center and a key component of the Lifespan health system, is committed to advancing medical research and improving patient care through innovative clinical trials. As a principal teaching hospital for The Warren Alpert Medical School of Brown University, it integrates cutting-edge research with high-quality clinical services. The hospital's extensive clinical trial program spans various fields, including oncology, cardiology, neurology, and more, aiming to enhance treatment options and patient outcomes. By fostering collaboration among researchers, clinicians, and patients, Rhode Island Hospital plays a pivotal role in translating scientific discoveries into effective therapies and improving healthcare delivery.

Locations

Providence, Rhode Island, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Kevin J Scully, MB BCh BAO

Principal Investigator

Rhode Island Hospital

Melissa S Putman, MD, MSc

Principal Investigator

Boston Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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