| Trial ID: | L7221 |
| Source ID: | NCT00330733
|
| Associated Drug: |
Salsalate
|
| Title: |
Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00330733/results
|
| Conditions: |
Atherosclerosis|Cardiovascular Disease|Inflammation|Insulin Resistance|Noninsulin-dependent Diabetes Mellitus
|
| Interventions: |
DRUG: Salsalate|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Systemic Glucose Disposal- Glucose Infusion Rates, Participants were admitted to the Clinical Research Units at 06:00-08:00 hours after an overnight fast. Euglycaemic-hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm-2 min-1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions., 3 months | Secondary: Glucose Area Under the Curve in These Subjects, 3 months|Plasma CRP, Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks., 8 and 12 weeks|Endothelial Function, Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel)., Baseline and 12 weeks|Plasma Interleukin 6, Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks., 8 and 12 weeks|Plasma sVCAM, Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks., 8 and 12 weeks|Plasma Adiponectin, Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks., 8 and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development | Collaborators: Joslin Diabetes Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
71
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2007-01
|
| Completion Date: |
2010-09
|
| Results First Posted: |
2014-04-22
|
| Last Update Posted: |
2020-01-21
|
| Locations: |
Carl T. Hayden VA Medical Center, Phoenix, Arizona, 85012, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00330733
|
