The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Contact Information
Primary
Kevin J Scully, MB BCh BAO
kevin_scully@brown.edu
401-444-5504
Backup
Melissa S Putman, MD, MSc
melissa.putman@childrens.harvard.edu
617-355-7476
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 15
Treatments
Experimental: Low Glycemic Load Diet
Feeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation
Leads: Rhode Island Hospital