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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 5, 2007 | ||||
| Last Updated Date | February 2, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The purpose of this study is to investigate the reason for the relationship between body weight and higher risk of venous problems. [ Time Frame: single time point ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The purpose of this study is to investigate the reason for the relationship between body weight and higher risk of venous problems. [ Time Frame: single time point ] | ||||
| Change History | Complete list of historical versions of study NCT00554541 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease | ||||
| Official Title ICMJE | Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease | ||||
| Brief Summary | Disease of the veins include blood clots, varicose veins, leg swelling, and sores on the legs. Venous disease is more common in overweight patients, but little is known as to why this is the case. This research project is investigating the relationship between body weight and function of the leg veins using a special non-invasive technique known as venous plethysmography. We hope to investigate the reason for the relationship between body weight and higher risk of vein problems. Approximately 45 people will take part in this study. Patients will be recruited from among three groups: normal weight people, overweight people, and obese people. Resting ankle-brachial index will be measured in both lower extremities to exclude the presence of peripheral arterial disease. Venous physiologic study using air plethysmography with positional maneuvers will be performed. Parameters to be measured will be outflow time, passive draining and refill time, and exercise venous plethysmography. All studies will be performed with the Phlebotest system (Osborn Medical). All study procedures will be done during one visit, and no further follow-up is required. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Estimated Completion Date | January 2009 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| 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 | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00554541 | ||||
| Responsible Party | Dr Heather Gornik, Cleveland Clinic Foundation | ||||
| Study ID Numbers ICMJE | 07-617 | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | February 2009 | ||||
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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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