Low fecal elastase-1 in type I diabetes mellitus

Background: Previous studies suggested impaired pancreatic exocrine function in type I diabetes patients, but have been limited by small or highly selected samples. Fecal elastase-1 has facilitated evaluation of pancreatic dysfunction in population-based studies. Methods: 112 type I diabetic patients (age SD: 37 +/- 11 years; 47% males; diabetes duration: 12.5 +/- 10.5 years) were consecutively selected from main regional diabetes centers in Essen, West-Germany. 116 non-diabetic control subjects, similar with respect to age and sex, were recruited from the same geographical region. Elastase-1 measurement was performed centrally by ELISA (ScheboTech, Germany). Results: Elastase-1 concentrations in type I diabetic patients were significantly lower than in control subjects (median; inter-quartile range: diabetic patients: 227, 98-386 mug/g stool; non-diabetic subjects: 544, 377-702 mug/g stool) (p < 0.01). Elastase-1 < 100 mug/g stool (El < 100) was found in 25.9% of diabetic and 5.2% of non-diabetic subjects, yielding an age-sex-adjusted prevalence Odds ratio (POR; 95% CI) for diabetes and El 100 of 6.9 (2.8-19.6). After adjusting for potential confounders (history of gastrointestinal diseases, smoking, alcohol consumption) the strong association remained (POR: 6.7; 2.7-19.2). Among patients with diabetes, El < 100 was associated with quality of glycemic control (HbA1c, change per 1%: POR 1.5; 1.1-2.0), diabetes duration (per year: POR 1.1; 1.03-1.2), and age at diabetes onset (per age year: POR 1.1; 1.02-1.1). No association was found with history of gastrointestinal diseases, smoking, or alcohol consumption (current, life-time). Conclusions: Fecal elastase-1 concentrations were lower in type I diabetes patients compared to control subjects, indicating impaired pancreatic exocrine function. Low elastase-1 was associated with poor metabolic control and longer diabetes duration.