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Completed
NCT05762653
Morphological Pancreatic Features in Diabetes Mellitus Type 2
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 94
Sponsor: Hospital Clinico Universitario de Santiago
Location: Hospital Clinico Universitario de Santiago Santiago de Compostela A Coruña
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.