Introduction: The prevalence of exocrine pancreatic insufficiency (EPI) in type 1 diabetes (T1D) is approximately 33%. We are investigating the timing of exocrine pancreatic loss in the pre-T1D period. We hypothesize that fecal elastase (FE-1) will be reduced prior to Stage 1 T1D and its rate of decline used to predict disease onset.
Methods: From two parallel nested case control studies within the TEDDY study, we compare longitudinal FE-1 levels in subjects who develop T1D by age 4 (Cohort A) and who develop persistent multiple islet autoantibodies by age 4 but have not developed dysglycemia or T1D by age 6 (Cohort B) with their respective autoantibody negative euglycemic controls. We included subjects with available sample prior to key endpoints. We excluded subjects with prematurity, pancreatic disease, or medical conditions associated with EPI.
Results: About1187 blinded samples from cases and controls have been evaluated. The median FE-1 level is 958 mcg/g with an interquartile range of 594-1480. 1.8% of samples meet criteria for EPI, defined by FE-1 less than 200 mcg/g.
Conclusion: The low percentage of EPI found, along with the range of FE-1 values, agrees with previous literature (Penno et al). Our study is ongoing as there are about 4700 samples to be run. We hypothesize that future results will demonstrate the efficacy of using FE-1 as a predictive biomarker for T1D progression.
K. Morneault-Gill: None. M. Guyot: None. J. Geston: None. C. Georgas: None. M. Campbell-Thompson: None. M.J. Haller: Consultant; Sanofi. Advisory Panel; SAB Biotherapeutics, Inc. Consultant; MannKind Corporation. B.S. Bruggeman: Research Support; Tandem Diabetes Care, Inc.
National Institute of Health (NIH NIDDK R03DK129971 and NIH K23DK131363), Pediatric Endocrine Society Clinical Scholar Award
