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COMPLETED
NCT05762653

Morphological Pancreatic Features in Diabetes Mellitus Type 2

Sponsor: Hospital Clinico Universitario de Santiago

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

94

Start Date

2022-02-03

Completion Date

2023-12-31

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain