| Trial ID: | L5119 |
| Source ID: | NCT01969084
|
| Associated Drug: |
Linagliptin
|
| Title: |
The Effect of Linagliptin on Mitochondrial and Endothelial Function
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01969084/results
|
| Conditions: |
Type II Diabetes Mellitus
|
| Interventions: |
DRUG: Linagliptin|DRUG: Placebo|OTHER: Microcirculation testing|OTHER: Macrocirculation testing|OTHER: MRI Scans
|
| Outcome Measures: |
Primary: Phosphocreatine (PCR) Recovery Time After Exhaustive or up to 6 Minutes of Leg Exercise., Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test., Baseline and 12 weeks | Secondary: Change in Muscle Oxygenation Recovery Time, Change in muscle oxygenation after ischemia inducing occlusion for 4 minutes., Baseline and 12 weeks|Changes in Vascular Reactivity in the Micro- and Macro-circulation., Change in markers of macro- and microvascular function from the baseline visit to the post-treatment visit between the two groups., Baseline and 12 weeks|Changes in SDF1-α and Substance P, Baseline and 12 weeks|Changes in Circulating Endothelial Progenitor Cell Phenotypes, The measurements of the various EPC phenotypes were performed at the Beth Israel Deaconess Flow Cytometry Core Facility. Immunofluorescent cell staining was performed on peripheral blood with the use of the fluorescent conjugated antibodies. 1.000.000 events per sample were acquired using a FACS LSR II analyzer (Becton Dickinson, Franklin Lakes, NJ, USA) and the results were analyzed using the Beckman Coulter Kaluza analysis software (Beckman Coulter Inc., Brea, CA, USA)., Baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Beth Israel Deaconess Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2016-07
|
| Results First Posted: |
2016-11-18
|
| Last Update Posted: |
2016-11-18
|
| Locations: |
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01969084
|
