Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men
This study has been completed.
Sponsor:
TNO Quality of Life
Information provided by:
TNO Quality of Life
ClinicalTrials.gov Identifier:
NCT00221052
First received: September 13, 2005
Last updated: October 10, 2006
Last verified: October 2006
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 10, 2006 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00221052 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men | ||||
| Official Title ICMJE | Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men | ||||
| Brief Summary | Overweight increases the risk to develop chronic diseases including type-2 diabetes and cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects is thought to play an important role in disease development. The purpose of this study is to determine the role of inflammation on glucose metabolism and insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on markers of inflammation and on parameters of glucose metabolism will be studied. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Diclofenac | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | van Erk MJ, Wopereis S, Rubingh C, van Vliet T, Verheij E, Cnubben NH, Pedersen TL, Newman JW, Smilde AK, van der Greef J, Hendriks HF, van Ommen B. Insight in modulation of inflammation in response to diclofenac intervention: a human intervention study. BMC Med Genomics. 2010 Feb 23;3:5. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00221052 | ||||
| Other Study ID Numbers ICMJE | TNO-P6374 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | TNO Quality of Life | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | TNO Quality of Life | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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