Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis (FEED-CF)

NCT05766774 NA RECRUITING

The goal of this study is to determine the extent to which excess dietary sugars serve as a precipitating factor in glucose intolerance in adults with cystic fibrosis (CF), a population at especially high risk for a unique form of diabetes (CF-related diabetes, CFRD) and with standard-of-care dietary recommendations (high-calorie, high-fat) that conflict with recommendations for other forms of diabetes. This trial will investigate if the typical high-sugar, high-fat CF diet plays a role in diabetes risk and visceral fat accumulation in people with CF. A total of 30 participants will get a low-added sugar, high-fat diet and the other 30 will get a standard CF diet with no sugar restrictions. Participants will be randomized to the diet group they are assigned. All foods will be provided for 8 weeks.

Details

Lead sponsor	Emory University
Phase	NA
Status	RECRUITING
Enrolment	60
Start date	2023-06-28
Completion	2028-06

Conditions

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes

Interventions

• Low-added sugar, high-fat diet
• High-added sugar, high-fat CF diet

Primary outcomes

• Change in acute insulin response to arginine (AIRarg) from baseline — Baseline and 8 weeks post intervention
  Participants will undergo a Glucose-Potentiated Arginine Stimulation (GPA) Test after a 10-12 hour overnight fast to measure acute insulin (AIRarg) responses during a 230 and 340 mg/dl glucose clamp. This test will measure changes in beta cell secretory capacity.
• Change in acute C-peptide (ACRarg) from baseline — Baseline and 8 weeks post intervention
  Participants will undergo a Glucose-Potentiated Arginine Stimulation (GPA) Test after a 10-12 hour overnight fast to measure acute C-peptide (ACRarg) responses during a 230 and 340 mg/dl glucose clamp. This test will measure changes in beta cell secretory capacity.
• Change in visceral adipose tissue from baseline — Baseline and 8 weeks post intervention
  Dual energy X-ray absorptiometry (DEXA)-derived measurement of visceral adipose tissue (VAT) will be assessed with a GE Lunar iDXA machine. This will enable assessment of changes in body composition over the study.
• Change in fasted plasma Eh[CySS] from baseline — Baseline and 8 weeks post intervention
  Change in plasma Cysteine/Cystine Redox Potential (Eh\[CySS\]) will be measured.

Countries

United States