Morphological Pancreatic Features in Diabetes Mellitus Type 2 (PANDIAM)

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