| Trial ID: | L5001 |
| Source ID: | NCT05597202
|
| Associated Drug: |
Semaglutide, 2.0 Mg/Ml
|
| Title: |
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
|
| Acronym: |
DOTAFLAME
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Semaglutide, 2.0 mg/mL
|
| Outcome Measures: |
Primary: Difference in coronary 68Ga-Dotatate uptake after treatment., The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax., 6 months | Secondary: Difference in bone marrow aspirates after treatment., The within subject comparison of bone marrow aspirates before and after semaglutide treatment, expressed as a difference in stem cell count., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Collaborators: Dutch Heart Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-01-01
|
| Completion Date: |
2024-04
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-09
|
| Locations: |
AMC, Amsterdam, Noord-Holland, 1105AZ, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT05597202
|