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NCT05762653
Morphological Pancreatic Features in Diabetes Mellitus Type 2
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Enrollment: 94
Sponsor: Hospital Clinico Universitario de Santiago
Location: Spain
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patients older than 18 years.Undergoing an upper endoscopic ultrasound for any indication other than pancreatic disease.Signed informed consent-Patients: Previous diagnosis of type-2 diabetes mellitus.Controls: Nondiabetic subjects, matched by age, gender, alcohol consumption, and smoking with patients.Exclusion Criteria:History of pancreatic disease or surgery.History of upper gastrointestinal surgery.Diabetes type other than type-2.Severe cardiovascular or respiratory disease.Lack of informed consent.
Source: ClinicalTrials.gov (NCT05762653). StuddyBuddy aggregates publicly available trial information.