Morphological Pancreatic Features in Diabetes Mellitus Type 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Diagnostic Test: Endoscopic ultrasound

• Registration Number: NCT05762653
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-07-05
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prevalence of pancreatic atrophy	Day 1	Size of the pancreas as evaluated by endoscopic ultrasound
Factors associated with pancreatic fibrosis	Day 1	Demographics and clinical data significantly associated with pancreatic fibrosis

Trial Locations

Locations (1)

Hospital Clinico Universitario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain