Diabetes Mellitus, Type 2PANDIAMNCT05762653
Morphological Pancreatic Features in Diabetes Mellitus Type 2
An observational study of Diabetes Mellitus, Type 2, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Endoscopic ultrasound
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
About this study
Official title: 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.
Read more
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
- Being tested
- Endoscopic ultrasound
- Keywords
- pancreatic fibrosis, endoscopic ultrasound, elastography, fecal elastase
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundDiagnostic test
Also called Fecal elastase test, Nutritional evaluation
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Case | Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. Receives: Diagnostic Test: Endoscopic ultrasound | |
| Control | Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. Receives: Diagnostic Test: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pancreatic fibrosis
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Measured: Day 1
Degree of impairment of exocrine pancreatic function
Quantification of fecal elastase and evaluation of the nutritional status
Measured: Up to 7 days
Secondary outcomes (2)
Prevalence of pancreatic atrophy
Size of the pancreas as evaluated by endoscopic ultrasound
Measured: Day 1
Factors associated with pancreatic fibrosis
Demographics and clinical data significantly associated with pancreatic fibrosis
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start3 Feb 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Enrique Domínguez-Muñoz, Hospital Clinico Universitario de Santiago
- Investigators
- J. Enrique Dominguez-Munoz, MD, PhD, Principal investigator, University Hospital of Santiago de Compostela, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762653
- Sponsor's protocol ID
- PAN-DM-01/2021
- Acronym
- PANDIAM
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.
- ClinicalTrials.gov ID
- NCT05762653
- Acronym / sponsor ID
- PANDIAM / PAN-DM-01/2021
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- pancreatic fibrosis, endoscopic ultrasound, elastography, fecal elastase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Endoscopic ultrasoundCases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
| Control | – | Diagnostic Test: Endoscopic ultrasoundControls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasoundAlso: Fecal elastase test, Nutritional evaluationEvaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation. | Diagnostic test | Case, Control |
Primary outcome
Degree of pancreatic fibrosis
Time frame: Day 1
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Degree of impairment of exocrine pancreatic function
Time frame: Up to 7 days
Quantification of fecal elastase and evaluation of the nutritional status
2 secondary outcomes
Prevalence of pancreatic atrophy
Time frame: Day 1
Factors associated with pancreatic fibrosis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Enrique Dominguez-Munoz, MD, PhD principal investigator
University Hospital of Santiago de Compostela, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pancreatic fibrosis (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.