| Trial ID: | L2629 |
| Source ID: | NCT05662189
|
| Associated Drug: |
68ga-Exendin-4
|
| Title: |
Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1diabetes|Type2diabetes|Pre Diabetes|Hyperinsulinism
|
| Interventions: |
DRUG: 68Ga-exendin-4|OTHER: mixed meal test
|
| Outcome Measures: |
Primary: BCF x M, BCFxM=parameters derived from mixed meal test Beta cell function(BCF)=BCFxM/BCM, through study completion, an average of 3 months after enrolment|pancreatic beta cell mass (BCM), Beta cell mass index (BCM) = 68GA-exendin-4 Standard Uptake Value (SUV)\*pancreatic volume, through study completion, an average of 3 months after enrolment|pancreatic beta cell function (BCF), BCFxM/BCM, through study completion, an average of 3 months after enrolment |
|
| Sponsor/Collaborators: |
Sponsor: Azienda Ospedaliero-Universitaria di Parma | Collaborators: University of Parma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2022-03-15
|
| Completion Date: |
2025-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-18
|
| Locations: |
Azienda Ospedaliero Universitaria di Parma, Parma, Pr, 43126, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT05662189
|
