Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Degree of pancreatic fibrosis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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-
- •Severe cardiovascular or respiratory disease.
- •Lack of informed consent.
Outcomes
Primary Outcomes
Degree of pancreatic fibrosis
Time Frame: Day 1
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Degree of impairment of exocrine pancreatic function
Time Frame: Up to 7 days
Quantification of fecal elastase and evaluation of the nutritional status
Secondary Outcomes
- Prevalence of pancreatic atrophy(Day 1)
- Factors associated with pancreatic fibrosis(Day 1)
Investigators
J. Enrique Domínguez-Muñoz
Director of the Department of Gastroenterology
Hospital Clinico Universitario de Santiago