Cystic Fibrosis Clinical Trial
— FEED-CFOfficial title:
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Confirmed CF diagnosis 2. Ages 18 years and older 3. Baseline estimated daily total added sugar intake >16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ). Exclusion Criteria: 1. Nocturnal tube feeds 2. BMI <18.5 kg/m2 3. Life expectancy < 12 months 4. Confirmed diagnosis of CFRD 5. Screening OGTT showing fasting hyperglycemia (=126 mg/dL) 6. Chronic steroid use 7. Current pregnancy or lactation 8. Inability/unwillingness to consume the majority of foods on the menu during the study period 9. MRI-incompatible metal that cannot be removed for testing 10. Uncontrolled exocrine pancreatic insufficiency/malabsorption 11. Clinically instability, defined as no changes in medical regimen (including medications and pulmonary exacerbations) for at least 21 days prior to study visit 12. Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use 13. Actively trying to gain or lose weight 14. Any food allergies or intolerances that cannot be accommodated 15. Any medical condition deemed by the a study physician or PI that may preclude completion of the study or interfere with primary end points. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in acute insulin response to arginine (AIRarg) from baseline | 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. | Baseline and 8 weeks post intervention | |
Primary | Change in acute C-peptide (ACRarg) from baseline | 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. | Baseline and 8 weeks post intervention | |
Primary | Change in visceral adipose tissue from baseline | 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. | Baseline and 8 weeks post intervention | |
Primary | Change in fasted plasma Eh[CySS] from baseline | Change in plasma Cysteine/Cystine Redox Potential (Eh[CySS]) will be measured. | Baseline and 8 weeks post intervention | |
Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) scale | The GSRS is a 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation.
Possible score range is 0-7, with 7 being the worst and 0 being the best (no symptoms). |
Baseline and 8 weeks post intervention | |
Secondary | Change in hepatic and pancreatic fat volume | Dual energy X-ray absorptiometry (DEXA)-derived measurement of visceral adipose tissue (VAT) for hepatic and pancreatic fat volume. Will be assessed with a GE Lunar iDXA machine. | Baseline and 8 weeks post intervention | |
Secondary | Change in fasted plasma Eh[GSSG] | Change in plasma glutathione disulfide (GSSG) (Eh[CySS]) will be measured. | Baseline and 8 weeks post intervention |
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