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Sponsors and Collaborators: |
Massachusetts General Hospital Amgen |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00413400 |
This study will investigate whether etanercept will result in improved inflammatory indices, glucose tolerance and endothelial function in patients with the metabolic syndrome.
Condition | Intervention |
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Metabolic Syndrome |
Drug: Etanercept Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Etanercept in Patients With the Metabolic Syndrome (II) |
Estimated Enrollment: | 40 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months
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2: Active Comparator |
Drug: Etanercept
50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months
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Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome, insulin resistance, and coronary artery disease (CAD). TNF-alpha is an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as in insulin resistance. TNF-alpha antagonists are clinically effective in the inflammation of arthritides, and have recently been shown by our group to decrease inflammatory cardiovascular risk markers in metabolic syndrome. Data suggests that adiponectin, a recently discovered adipocytokine that may protect against the development of insulin resistance and atherosclerosis, may be downregulated by TNF-alpha. In addition, population based studies have shown that those with the highest levels of TNF-alpha have an increased relative risk of cardiovascular morbidity while rheumatoid arthritis patients treated with TNF-alpha blockade appear protected from cardiovascular disease. We will perform a 6-month study in which we will administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic syndrome to investigate its effect on surrogate markers of cardiovascular disease, including inflammatory markers, adiponectin and glucose tolerance and endothelial function. The results of the proposed study will have broad implications regarding the physiological role of TNF-alpha on the inflammatory cascade, cardiovascular indices and endothelial function.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Plus two of the following:
Exclusion Criteria:
Contact: Steven K Grinspoon, MD | 617 724-9109 | sgrinspoon@partners.org |
United States, Massachusetts | |
MGH | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Steven K Grinspoon, MD 617-724-9109 | |
Principal Investigator: Steven K Grinspoon, MD |
Principal Investigator: | Steven K Grinspoon | MGH |
Principal Investigator: | Steven K Grinspoon | MGH |
Responsible Party: | Massachusetts General Hospital ( Steven Grinspoon, MD ) |
Study ID Numbers: | 2006-P-001060 |
Study First Received: | December 7, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00413400 |
Health Authority: | United States: Food and Drug Administration |
Inflammation Visceral adiposity TNF Adiponectin |
glucose tolerance endothelial function metabolic syndrome |
Obesity TNFR-Fc fusion protein Inflammation |
Anti-Inflammatory Agents Disease Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |