MedTrace Logo

Morphological Pancreatic Features in Diabetes Mellitus Type 2

NCT05762653 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2023-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • J. Enrique Dominguez-Munoz, MD, PhD · University Hospital of Santiago de Compostela, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05762653 on ClinicalTrials.gov