An observational study in Diabetes Mellitus, Type 2, sponsored by Hospital Clinico Universitario de Santiago. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Hospital Clinico Universitario de Santiago · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 94 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospital Clinico Universitario de Santiago is the lead sponsor of 33 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.
Exclusion Criteria:
Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
Diagnostic Test: Endoscopic ultrasound
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
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.
Also known as: Fecal elastase test, Nutritional evaluation
Degree of pancreatic fibrosis
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Time frame: Day 1
Degree of impairment of exocrine pancreatic function
Quantification of fecal elastase and evaluation of the nutritional status
Time frame: Up to 7 days
Prevalence of pancreatic atrophy
Size of the pancreas as evaluated by endoscopic ultrasound
Time frame: Day 1
Factors associated with pancreatic fibrosis
Demographics and clinical data significantly associated with pancreatic fibrosis
Time frame: Day 1
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hospital Clinico Universitario de Santiago