Hypothesis: Type 2 diabetes mellitus is associated with pancreatic fibrosis that can be evaluated by minimally invasive imaging techniques. That fibrosis is associated with alteration of exocrine pancreatic function, defined as a reduced secretion of pancreatic enzymes and the development of nutritional deficiencies. To test that hypothesis, a prospective, observational, cross-sectional, comparative, case-control study has been designed. Pancreatic fibrosis will be evaluated by endoscopic ultrasound and quantitative elastography in cases (type-2 diabetes) and age-gender-matched controls without diabetes. Pancreatic function will be explored by fecal elastase test and nutritional evaluation. Calculated sample size is 94 patients (47 cases and 47 controls). Study period is 2 years.
Study Type
OBSERVATIONAL
Enrollment
94
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Degree of pancreatic fibrosis
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Time frame: Day 1
Degree of impairment of exocrine pancreatic function
Quantification of fecal elastase and evaluation of the nutritional status
Time frame: Up to 7 days
Prevalence of pancreatic atrophy
Size of the pancreas as evaluated by endoscopic ultrasound
Time frame: Day 1
Factors associated with pancreatic fibrosis
Demographics and clinical data significantly associated with pancreatic fibrosis
Time frame: Day 1
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