Morphological Pancreatic Features in Diabetes Mellitus Type 2

Study Overview
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Brief Summary
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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
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Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Diagnostic Test: Endoscopic ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. | Diagnostic Test: Endoscopic ultrasound<br>* Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.<br>* Other names: Nutritional evaluation;|
| Control<br>Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. | Diagnostic Test: Endoscopic ultrasound<br>* Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.<br>* Other names: Nutritional evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pancreatic fibrosis | Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography. | Day 1 | 
| Degree of impairment of exocrine pancreatic function | Quantification of fecal elastase and evaluation of the nutritional status | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pancreatic atrophy | Size of the pancreas as evaluated by endoscopic ultrasound | Day 1 | 
| Factors associated with pancreatic fibrosis | Demographics and clinical data significantly associated with pancreatic fibrosis | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic fibrosis, endoscopic ultrasound, elastography, fecal elastase