RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05723445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and above
  2. * Genetically confirmed diagnosis of CF
  3. * Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
  4. * Criteria for CFRD:
  1. * FEV1 \<50% predicted on most recent pulmonary function testing
  2. * BMI \<18 kg/m2
  3. * Currently receiving enteral nutrition support via GT feeds
  4. * Pregnancy, plan to become pregnant in the next 3-months, or sexually active without use of contraception
  5. * Use of IV antibiotics or systemic supraphysiologic glucocorticoids for CF exacerbation within 1 month
  6. * Started or stopped treatment with a CFTR modulator within 3 months of enrollment
  7. * Currently adhering to an LGL or other carbohydrate-restricted diet (carbohydrate intake \<30% of total daily caloric intake)

Contacts and Locations

Study Contact

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

Principal Investigator

Kevin J Scully, MB BCh BAO
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Melissa S Putman, MD, MSc
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Kevin J Scully, MB BCh BAO, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital
  • Melissa S Putman, MD, MSc, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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