Morphological Pancreatic Features in Diabetes Mellitus Type 2

Diabetes Mellitus, Type 2 Clinical Trial

— PANDIAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762653
• Other study ID #: PAN-DM-01/2021
• Status: Recruiting
• Start date: February 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: Beatriz Cigarran, MD
• Phone: -34 981 951 364
• Email: beacigarran[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of pancreatic fibrosis	Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.	Day 1
Primary	Degree of impairment of exocrine pancreatic function	Quantification of fecal elastase and evaluation of the nutritional status	Up to 7 days
Secondary	Prevalence of pancreatic atrophy	Size of the pancreas as evaluated by endoscopic ultrasound	Day 1
Secondary	Factors associated with pancreatic fibrosis	Demographics and clinical data significantly associated with pancreatic fibrosis	Day 1