Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
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|ClinicalTrials.gov Identifier: NCT00330733|
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : April 22, 2014
Last Update Posted : January 21, 2020
The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications.
The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Cardiovascular Disease Inflammation Insulin Resistance Noninsulin-dependent Diabetes Mellitus||Drug: Salsalate Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Placebo Comparator: Placebo
Participants were randomized to 12-week treatment matching the active salsalate arm.
Active Comparator: Salsalate Therapy
Participants were randomized to 12-week treatment with up to 4 g/day.
- Change in Systemic Glucose Disposal- Glucose Infusion Rates [ Time Frame: 3 months ]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.
- Glucose Area Under the Curve in These Subjects [ Time Frame: 3 months ]
- Plasma CRP [ Time Frame: 8 and 12 weeks ]Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks.
- Endothelial Function [ Time Frame: Baseline and 12 weeks ]Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel).
- Plasma Interleukin 6 [ Time Frame: 8 and 12 weeks ]Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.
- Plasma sVCAM [ Time Frame: 8 and 12 weeks ]Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.
- Plasma Adiponectin [ Time Frame: 8 and 12 weeks ]Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330733
|United States, Arizona|
|Carl T. Hayden VA Medical Center|
|Phoenix, Arizona, United States, 85012|
|Principal Investigator:||Peter Reaven, MD||Carl T. Hayden VA Medical Center|