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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
| |
| Control | Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound | Diagnostic Test | Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Cigarran, MD | Contact | -34 981 951 364 | beacigarran@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| J. Enrique Dominguez-Munoz, MD, PhD | University Hospital of Santiago de Compostela, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario de Santiago | Recruiting | Santiago de Compostela | A Coruña | 15706 | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Day 1 |
| D004700 | Endocrine System Diseases |