| Trial ID: | L6993 |
| Source ID: | NCT00523393
|
| Associated Drug: |
Insulin Glargin
|
| Title: |
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Insulin Glargin|DRUG: Human Insulin
|
| Outcome Measures: |
Primary: Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis, 4 weaks of treatment | Secondary: Change of number of circulating EPC 4 as detected by in vitro outgrowth, 4 weeks, 4 months|Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation), 4 months|Myocardial function and myocardial perfusion reserve as measured by MRI, 4 months|Intima-Media-Thickness, 4 months|Long-term Glucose control (HbA1c), 4 weeks, 4 months|Short-term Glucose control (fasting glucose), 4 weeks, 4 months|Markers of inflammation and vascular risk in diabetes, 4 weeks, 4 months
|
| Sponsor/Collaborators: |
Sponsor: Heidelberg University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2007-08
|
| Completion Date: |
2010-05
|
| Results First Posted: |
|
| Last Update Posted: |
2009-02-13
|
| Locations: |
University Clinics Heidelberg, Dept. Medicine1, Heidelberg, 69120, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00523393
|
