NCT05762653

Morphological Pancreatic Features in Diabetes Mellitus Type 2

Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 94 (estimated)
• Sponsor: Hospital Clinico Universitario de Santiago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Endoscopic ultrasound	Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.

Timeline

• Start date: 2022-02-03
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2023-03-09
• Last updated: 2023-03-09

Locations

1 site across 1 country: Spain