Morphological Pancreatic Features in Diabetes Mellitus Type 2

NCT05762653 | Unknown

• 1 other identifier: PAN-DM-01/2021
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

pancreatic fibrosis; endoscopic ultrasound; elastography; fecal elastase

Outcome Measures

Primary Outcomes (2)

• Degree of pancreatic fibrosis

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

  Day 1

• Degree of impairment of exocrine pancreatic function

  Quantification of fecal elastase and evaluation of the nutritional status

  Up to 7 days

Secondary Outcomes (2)

• Prevalence of pancreatic atrophy

  Day 1

• Factors associated with pancreatic fibrosis

  Day 1

Study Arms (2)

Case

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

Diagnostic Test: Endoscopic ultrasound

Control

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

Diagnostic Test: Endoscopic ultrasound

Interventions

Endoscopic ultrasound DIAGNOSTIC_TEST

Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.

Also known as: Fecal elastase test, Nutritional evaluation

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• J. Enrique Dominguez-Munoz, MD, PhD

  University Hospital of Santiago de Compostela, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Cigarran, MD

CONTACT

-34 981 951 364; beacigarran@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Gastroenterology

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: March 9, 2023
• Study Start: February 3, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

ES (1)