Morphological Pancreatic Features in Diabetes Mellitus Type 2 (PANDIAM)

February 28, 2023 updated by: J. Enrique Domínguez-Muñoz, Hospital Clinico Universitario de Santiago

Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pancreatic fibrosis
Time Frame: Day 1
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Day 1
Degree of impairment of exocrine pancreatic function
Time Frame: Up to 7 days
Quantification of fecal elastase and evaluation of the nutritional status
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of pancreatic atrophy
Time Frame: Day 1
Size of the pancreas as evaluated by endoscopic ultrasound
Day 1
Factors associated with pancreatic fibrosis
Time Frame: Day 1
Demographics and clinical data significantly associated with pancreatic fibrosis
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-DM-01/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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