- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05762653
Morphological Pancreatic Features in Diabetes Mellitus Type 2 (PANDIAM)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Beatriz Cigarran, MD
- Phone Number: -34 981 951 364
- Email: beacigarran@gmail.com
Study Locations
-
-
A Coruña
-
Santiago de Compostela, A Coruña, Spain, 15706
- Recruiting
- Hospital Clinico Universitario De Santiago
-
Contact:
- J. Enrique Dominguez-Munoz, MD, PhD
- Phone Number: +34 981951364
- Email: juan.enrique.dominguez.munoz@sergas.es
-
Contact:
- Julio Iglesias-Garcia, MD. PhD
- Phone Number: +34 981951364
- Email: julioiglesiasgarcia@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography.
Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Other Names:
|
Control
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
|
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography.
Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Other Names:
|
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
Investigators
- Principal Investigator: J. Enrique Dominguez-Munoz, MD, PhD, University Hospital of Santiago de Compostela, Spain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
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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