Inflammation Clinical Trial
Official title:
Synergistic Effect of Simvastatin and Ezetimibe on Lipid and Pro-inflammatory Profiles in Pre-diabetic Subjects
Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but data concerning the pleiotropic effects of this combination are controversial. We tested the hypothesis that the combination of simvastatin and ezetimibe would induce improvement in inflammatory status, as reflected by leukocyte count and CRP, IL-6 and TNF-a levels. This open-label trial evaluated whether this combination results in a synergistic effect the pro-inflammatory status of pre-diabetic subjects. Fifty pre-diabetic subjects were randomly assigned to one of 2 groups, one receiving ezetimibe (10 mg/d), the other, simvastatin (20 mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2007 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Both sexes, aged from 18 to 75 years, with a body mass index ranging from 25 to 40 kg/m2 and pre-diabetes (impaired glucose tolerance or impaired fasting glucose). Exclusion Criteria: - Blood triglyceride concentration >350 mg/dl and LDL cholesterol >200 mg/dl, unstable blood pressure, clinical evidences of cardiovascular, hepatic or renal diseases, use of anti-inflammatory agents or others interfering with lipid or glucose metabolism. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital do Rim e Hipertensao da UNIFESP | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C reactive protein | CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases. | Serum C reactive protein was detected at baseline, before starting monotherapy with simvastatin or ezetimibe, and after 12 weeks of each monotherapy | No |
Primary | C reactive protein | CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases. | C reactive protein (CRP) concentration was determined after 12 weeks of monotherapy (simvastatin or ezetimibe) and was compared with the concentration after more 12 weeks of combined therapy | No |
Primary | C reactive protein | CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases. | Serum C reactive protein (CRP) concentration detected at baseline was compared with that obtained after of combined therapy of simvastatin plus ezetimibe (week 24) | No |
Secondary | Interleukin-6 | Interleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes. | Circulating interleukin-6 concentration was determined at baseline (before monotherapy with simvastatin or ezetimibe) and after a 12-week period of each monotherapy | No |
Secondary | Tumor necrosis factor alpha | Tumor necrosis factor alfa (TNF-alpha) is secreted by adipose tissue and released to blood. Circulating levels of TNF-alpha may be indicative of a proinflammatory status, which is a initiating mechanism of metabolic and cardiovascular abnormalities. | Tumor necrosis factor alfa concentration was determined at baseline (before monotherapy with simvastatin or ezetimibe) and after a 12-week period of each monotherapy | No |
Secondary | Interleukin-6 | Interleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes. | Interleukin-6 concentration was determined after 12 weeks of monotherapy with simvastatin or ezetimibe and compared with the concentrations after more 12 weeks of combined therapy | No |
Secondary | Tumor Necrosis Factor Alpha | Tumor necrosis factor alfa (TNF-alpha) is secreted by adipose tissue and released to blood. Circulating levels of TNF-alpha may be indicative of a proinflammatory status, which is a initiating mechanism of metabolic and cardiovascular abnormalities. | Serum tumor necrosis factor alpha concentration was determined after 12 weeks of monotherapy with simvastatin or ezetimibe and compared with the concentrations after more 12 weeks of combined therapy | No |
Secondary | Interleukin-6 | nterleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes. | Interleukin-6 concentration detected at baseline was compared with that obtained after of combined therapy of simvastatin plus ezetimibe (week 24) | No |
Secondary | Tumor necrosis factor alpha | Tumor necrosis factor alfa (TNF-alpha) is secreted by adipose tissue and released to blood. Circulating levels of TNF-alpha may be indicative of a proinflammatory status, which is a initiating mechanism of metabolic and cardiovascular abnormalities. | Tumor necrosis factor alpha concentration detected at baseline was compared with that obtained after of combined therapy of simvastatin plus ezetimibe (week 24) | No |
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