| Trial ID: | L7368 |
| Source ID: | NCT03449654
|
| Associated Drug: |
Liraglutide
|
| Title: |
Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes
|
| Acronym: |
LIRAFLAME
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Liraglutide|DRUG: Placebo (for liraglutide)
|
| Outcome Measures: |
Primary: Change in vascular inflammation, Change in vascular inflammation assessed by FDG PET/CT, baseline to week 26 | Secondary: Change in Endothelial dysfunction, Change in endothelial dysfunction assessed with endo-PAT, baseline to week 26|Change in Endothelial dysfunction, Change in endothelial dysfunction, assessed as sublingual glycocalyx measurement, baseline to week 13 and 26|Coronary artery calcium score, Change coronary artery calcium score (absolute values), baseline to week 26|Carotid intima media thickness, Change in carotid intima media thickness measured by ultrasound, baseline to week 26 | Other: Autonomic nervous system function, Change in cardiovascular autonomic neuropathy indices, baseline to week 26
|
| Sponsor/Collaborators: |
Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Department of Clinical Physiology, Nuclear Medicine & PET, Rigshospitalet & Cluster for Molecular Imaging, University of Copenhagen, Denmark
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-10-26
|
| Completion Date: |
2019-08-16
|
| Results First Posted: |
|
| Last Update Posted: |
2020-06-11
|
| Locations: |
Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT03449654
|
