Am J Clin Nutr. 2023 Dec 1:S0002-9165(23)66288-4. doi: 10.1016/j.ajcnut.2023.11.016. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with short bowel syndrome (SBS) receiving home parenteral nutrition (HPN) commonly cycle nutritional infusions overnight likely contributing to circadian misalignment and sleep disruption.

OBJECTIVE: The objective of this quasi-experimental, single-arm, controlled, pilot trial was to examine the feasibility, safety, and efficacy of daytime infusions of HPN in adults with SBS without diabetes.

DESIGN: Enrolled patients were fitted with a continuous glucose monitor and wrist actigraph and were instructed to cycle their infusions overnight for 1 week followed by daytime for another week (ClinicalTrials.gov: NCT04743960). 24-hour average blood glucose, the time spent above 140 mg/dL or below 70 mg/dL, and sleep fragmentation were derived for each week and compared using Wilcoxon signed-rank test. Patient-reported quality of life outcomes were also compared between the weeks.

RESULTS: Twenty patients (mean age, 52 years; 75% female; mean BMI 21.5 kg/m2) completed the trial. Overnight infusions started at 21:00 and daytime infusions started at 09:00. No serious adverse events were noted. There were no differences in 24-hour glycemia (median (95% confidence interval): daytime=3.00(87.7,99.9)mg/dL vs. overnight=91.1(89.6,99.0)mg/dL; P=0.922). During the day hours (09:00-21:00), average glucose was 13.5 (5.7,22.0) mg/dL higher, and the time spent below 70 mg/dL was 15.0 (-170.0,22.5) minutes lower with daytime HPN compared to overnight. Conversely, during the night hours (21:00-09:00), average glucose was 16.6 (-23.1,-2.2) mg/dL lower with daytime HPN compared to overnight. There were no differences in actigraphy-derived measures of sleep and activity, however, sleep timing was later and light at night exposure was lower with daytime HPN compared to overnight HPN. Patients reported less sleep disruptions due to urination and fewer episodes of uncontrollable diarrhea or ostomy output with daytime HPN.

CONCLUSION: Daytime HPN was feasible and safe in adults with SBS, and compared to overnight HPN, improved subjective sleep without increasing 24-hour glucose levels.

TRIAL REGISTRATION: Registration ID: NCT04743960 (ClinicalTrials.Gov); URL: https://classic.

CLINICALTRIALS: gov/ct2/show/NCT04743960.

PMID:38043867 | DOI:10.1016/j.ajcnut.2023.11.016