Morfologiske bugspytkirteltræk ved diabetes mellitus type 2 (PANDIAM)
Morfologiske træk ved bugspytkirtlen hos patienter med type 2-diabetes mellitus: sammenhæng med sygdommens kliniske træk.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
A Coruña
-
Santiago de Compostela, A Coruña, Spanien, 15706
- Hospital Clinico Universitario de Santiago
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Case
Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Andre navne:
|
|
Control
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Degree of pancreatic fibrosis
Tidsramme: Day 1
|
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography. |
Day 1
|
|
Degree of impairment of exocrine pancreatic function
Tidsramme: Up to 7 days
|
Quantification of fecal elastase and evaluation of the nutritional status |
Up to 7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of pancreatic atrophy
Tidsramme: Day 1
|
Size of the pancreas as evaluated by endoscopic ultrasound |
Day 1
|
|
Factors associated with pancreatic fibrosis
Tidsramme: Day 1
|
Demographics and clinical data significantly associated with pancreatic fibrosis |
Day 1
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: J. Enrique Dominguez-Munoz, MD, PhD, University Hospital of Santiago de Compostela, Spain
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PAN-DM-01/2021
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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