Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05762653). StuddyBuddy aggregates publicly available trial information.