| Trial ID: | L4114 |
| Source ID: | NCT00982358
|
| Associated Drug: |
Valsartan
|
| Title: |
Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Type 2 Diabetes Mellitus|Coronary Artery Disease
|
| Interventions: |
DRUG: Valsartan|OTHER: Placebo
|
| Outcome Measures: |
Primary: The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα) in serum after 16 weeks of treatment. | Secondary: To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.|To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma|To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue|To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.|To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD
|
| Sponsor/Collaborators: |
Sponsor: Charite University, Berlin, Germany | Collaborators: University of Ulm
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
121
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-07
|
| Completion Date: |
2007-03
|
| Results First Posted: |
|
| Last Update Posted: |
2009-09-23
|
| Locations: |
University of Ulm, Department of Internal Medicine II, Ulm, Baden-Wuerttemberg, 89081, Germany|Charité University Medicine Berlin, Center for Cardiovascular Research, Outpatient Clinic, Berlin, 10115, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00982358
|
