Morphological Pancreatic Features in Diabetes Mellitus Type 2
NCT ID: NCT05762653
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
94 participants
OBSERVATIONAL
2022-02-03
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population
NCT06826729
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
NCT05764629
Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis
NCT06590935
Examination of the Pancreas in New-onset Diabetes
NCT02001337
Pancreatic Islet Function, Insulin Sensitivity, and Chronic Complications in Pre-Diabetes
NCT00172796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Case
Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
Endoscopic ultrasound
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Control
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication.
Endoscopic ultrasound
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopic ultrasound
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 upper gastrointestinal surgery.
* Diabetes type other than type-2.
* Severe cardiovascular or respiratory disease.
* Lack of informed consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Clinico Universitario de Santiago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
J. Enrique Domínguez-Muñoz
Director of the Department of Gastroenterology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
J. Enrique Dominguez-Munoz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Santiago de Compostela, Spain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAN-DM-01/2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.