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Brief Title † | Effects of Infliximab on Insulin Sensitivity and Beta Cell Function in Insulin Resistant Human Obesity | ||||
Official Title † | A Prospective Trial of Anti-TNF-Alpha Chimeric Monoclonal Antibody (Infliximab, Remicade®) on Insulin Sensitivity, Beta Cell Function and Cardiovascular Risk Profile in Insulin Resistant Human Obesity | ||||
Brief Summary | The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in obese male subjects. |
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Detailed Description | Overweight and obesity are rapidly becoming one of the most pressing health problems. Obese subjects face an increased risk for cardiovascular events that is closely related to a cluster of metabolic disturbances (i.e. insulin resistance, hypertension, dyslipidemia and impaired fibrinolysis), collectively referred to as syndrome X. The actual mechanism underlying development of syndrome X has not been elucidated. Increased TNF-alpha activity has been proposed as a key factor. The objectives of the study are to test whether neutralizing TNF-alpha with infliximab in obese subjects affects insulin resistance and phenotypical manifestations of the metabolic syndrome such as:
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Primary Outcome Measure † | Change in fasting insulin levels [ Time Frame: 70 days ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | Blood pressure; Vascular reactivity; Blood measurements + calculation of the HOMA; Iv-GTT; Body fat mass (DEXA); Safety; [ Time Frame: 70 days ] [ Designated as safety issue: Yes ] | ||||
Condition † | Obesity Insulin Resistance Metabolic Syndrome |
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Intervention † | Biological: Infliximab | ||||
MEDLINE PMIDs | |||||
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Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 9 | ||||
Start Date † | September 2005 | ||||
Completion Date | September 2007 | ||||
Eligibility Criteria † | Inclusion Criteria:
Adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion. Hemoglobin >= 8.5 g/dL WBC >= 3.5 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L SGOT (AST) and AP <3xULN Chest radiograph within 3 months prior to first infusion with no evidence of malignancy, infection or fibrosis. No history of latent or active TB prior to screening. No signs or symptoms suggestive of active TB upon medical history and/or physical examination. No recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent Have a chest radiograph taken within 3 months prior to the first administration of study agent with no evidence of current active TB or old inactive TB. Exclusion Criteria:
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Gender | Male | ||||
Ages | 20 Years to 50 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Austria | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00636142 | ||||
Organization ID | 2005-000181-39 | ||||
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Study Sponsor † | Medical University of Graz | ||||
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Investigators † |
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Information Provided By | Medical University of Graz | ||||
Verification Date | March 2008 | ||||
First Received Date † | March 11, 2008 | ||||
Last Updated Date | March 13, 2008 |