Abstract

Introduction: type 1 diabetes mellitus (T1DM) has been described as a cause of exocrine pancreatic exocrine (EPI). However, the value of Pancreatic Elastase-1 in stools (PE-1) in these patients has been discussed. Aim: to analyze the levels of PE-1 in a group of T1DM patients and to establish its clinical implications. Methods: cross-sectional study approved by de ethics committee of our centre. T1DM and LADA (Latent Autoimmune Diabetes in Adults) aged 18 or older were referred to our department from the Endocrinology Service. All participants signed an informed consent. We analyzed the levels of PE-1 (ELISA with monoclonal antibodies, normal value > 200 mcg/g) in all patients. Then, we tried to define the relationship between those levels with demographic variables and variables related to the diabetes evolution such as age at diagnosis, years since diagnosis was made, levels of HbA1c, presence of gastrointestinal symptoms or complications (nephropathy, neuropathy or retinopathy). Finally we compared the results of PE-1 with those of the mixed 13Ctriglyceride (13C-MTG) breath test (normal value > 29%). Data were analyzed using the independent-samples t-test, the Mann-Whitney U test and the chi-square test. Correlation between quantitative variables was made using the Pearson's correlation coefficient (r). To analyze the agreement between the categorical results of both test we used the kappa coefficient (κ). Results: 100 patients (50 male). Mean age: 45.8 + 11.75. T1DM/LADA: 93/ 7. 71 were smokers and 20 recognized alcohol consumption > 20 g/day. Mean PE-1 level: 249.5 + 158.3. In 43 cases its level was below the cutoff value. 22 of them had levels < 100. The PE-1 level was not correlated with age, years since diagnosis or C-Peptide levels. An inverse correlation was found between PE-1 and HbA1c levels (r: -0.30, p=0.003). No statistically significant differences were found in PE-1 levels comparing sex, type of diabetes, presence of symptoms, smoking or alcohol consumption. However PE-1 levels were 98.6 mcg/g (95% CI: 38.8-159.5, p=0.002) lower in patients diagnosed with diabetes-related complications. 13C-MTG breath test were performed in 86 patients. It was altered in 5 cases (5.8%). Only two of them had also a pathologic PE-1. There was no agreement between both tests (κ=0.005, p=0.93). The same way, no correlation was found (r=0.06, p=0.58). Conclusions: Low PE-1 levels are frequent (43%) in T1DM patients. PE-1 levels are lower in patients with diabetes-related complications and in those with poor glycemic control. Despite low PE-1 levels, fat absorption seems to be preserved in most cases. Therefore, low PE-1 levels in T1DM should be taken cautiously since they may not mean real EPI.

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