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PANDIAM: Morphological Pancreatic Features in Diabetes Mellitus Type 2

Sponsor
Hospital Clinico Universitario de Santiago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05762653
Collaborator
(none)
94
Enrollment
1
Location
22.9
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Endoscopic ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
94 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.
Actual Study Start Date :
Feb 3, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Case

Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication.

Diagnostic Test: Endoscopic ultrasound
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Other Names:
  • Fecal elastase test
  • Nutritional evaluation

    		•
    Control

    Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication.

    Diagnostic Test: Endoscopic ultrasound
    Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
    Other Names:
  • Fecal elastase test
  • Nutritional evaluation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degree of pancreatic fibrosis [Day 1]

      Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.

    2. Degree of impairment of exocrine pancreatic function [Up to 7 days]

      Quantification of fecal elastase and evaluation of the nutritional status

    Secondary Outcome Measures

    1. Prevalence of pancreatic atrophy [Day 1]

      Size of the pancreas as evaluated by endoscopic ultrasound

    2. Factors associated with pancreatic fibrosis [Day 1]

      Demographics and clinical data significantly associated with pancreatic fibrosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinico Universitario de Santiago Santiago de Compostela A Coruña Spain 15706

    Sponsors and Collaborators

    • Hospital Clinico Universitario de Santiago

    Investigators

    • Principal Investigator: J. Enrique Dominguez-Munoz, MD, PhD, University Hospital of Santiago de Compostela, Spain

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    J. Enrique Domínguez-Muñoz, Director of the Department of Gastroenterology, Hospital Clinico Universitario de Santiago
    ClinicalTrials.gov Identifier:
    NCT05762653
    Other Study ID Numbers:
    • PAN-DM-01/2021
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 9, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by J. Enrique Domínguez-Muñoz, Director of the Department of Gastroenterology, Hospital Clinico Universitario de Santiago
    pancreatic fibrosis
    endoscopic ultrasound
    elastography
    fecal elastase
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Mar 9, 2023