Status:
COMPLETED
A Pilot Study of a Low Glycemic Load Diet in Adults With Cystic Fibrosis
Lead Sponsor:
Boston Children's Hospital
Conditions:
Cystic Fibrosis
Cystic Fibrosis-related Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will b...
Detailed Description
Non-pulmonary complications of cystic fibrosis (CF) are becoming increasingly prevalent with the changing landscape of CF care. CF related diabetes mellitus (CFRD) and CF related gastrointestinal (GI)...
Eligibility Criteria
Inclusion
- Diagnosis of CF
- Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
- Oral glucose tolerance test within the past three years showing impaired glucose tolerance (2-hour glucose ≥140 mg/dL) or indeterminate glycemia (1-hour glucose ≥200), HbA1c 5.7-6.4% in the past one year, and/or or documented random glucose ≥200 in the past one year
- BMI 21-25 kg/m2
- 18 years and above
Exclusion
- Current use of insulin
- Most recent HbA1c ≥6.5%
- History of solid organ transplant or currently listed for solid organ transplant
- FEV1 \<50% predicted on most recent pulmonary function testing
- Currently receiving enteral nutrition support
- Current or anticipated pregnancy in the next 1 year
- Hospitalization for CF exacerbation within 1 month of enrollment
- Started or stopped treatment with Trikafta or other CFTR modulator within 3 months of enrollment
- Currently adhering to a low glycemic index or other carbohydrate restricted diet
Key Trial Info
Start Date :
October 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04519853
Start Date
October 25 2021
End Date
July 1 2023
Last Update
August 14 2023
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115