Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
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.
Peripheral Arterial Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease|
- 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 ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||January 2009|
|Estimated Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Normal Body-Mass Index: 18.5-24.9
Obese Body-Mass Index: 30.0-39.9
Morbidly Obese Body-Mass Index: ≥ 40
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554541
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Heather Gornik, MD, RVT||The Cleveland Clinic|