Diabetes Mellitus, Type 2
Conditions
Keywords
pancreatic fibrosis, endoscopic ultrasound, elastography, fecal elastase
Brief 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.
Interventions
DIAGNOSTIC_TESTEndoscopic ultrasound
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Sponsors
Hospital Clinico Universitario de Santiago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pancreatic fibrosis | Day 1 | Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography. |
| Degree of impairment of exocrine pancreatic function | Up to 7 days | Quantification of fecal elastase and evaluation of the nutritional status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of pancreatic atrophy | Day 1 | Size of the pancreas as evaluated by endoscopic ultrasound |
| Factors associated with pancreatic fibrosis | Day 1 | Demographics and clinical data significantly associated with pancreatic fibrosis |
Countries
Spain
Contacts
Primary ContactBeatriz Cigarran, MD
Outcome results
None listed