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Morphological Pancreatic Features in Diabetes Mellitus Type 2 (PANDIAM)

H

Hospital Clinico Universitario de Santiago

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Diagnostic Test: Endoscopic ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT05762653
PAN-DM-01/2021

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

94 participants in 2 patient groups

Case
Description:
Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
Treatment:
Diagnostic Test: Endoscopic ultrasound
Control
Description:
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
Treatment:
Diagnostic Test: Endoscopic ultrasound

Trial contacts and locations

1

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Central trial contact

Beatriz Cigarran, MD

Data sourced from clinicaltrials.gov

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