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Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
This study has been terminated.
( Lack of study subjects )
Study NCT00554541   Information provided by The Cleveland Clinic
First Received: November 5, 2007   Last Updated: February 2, 2009   History of Changes

November 5, 2007
February 2, 2009
November 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00554541 on ClinicalTrials.gov Archive Site
 
 
 
Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
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.

 
 
Observational
Cohort, Prospective
  • Obesity
  • Peripheral Arterial Disease
 
  • Normal Body-Mass Index: 18.5-24.9
  • Obese Body-Mass Index: 30.0-39.9
  • Morbidly Obese Body-Mass Index: ≥ 40
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
45
January 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18-60 years old
  • BMI within one of three strata (Normal: 18.5-24.9, Obese: 30.0-39.9, Morbidly Obese: ≥ 40)

Exclusion Criteria:

  • Prior diagnosis of chronic venous insufficiency or venous stasis ulceration
  • Prior diagnosis of lymphedema
  • Significant lower extremity edema as determined by study investigators. Lipidemia (in the absence of venous or lymphatic related edema) is acceptable.
  • Varicose veins (subcutaneous dilated vein > 3 mm in diameter measured in upright position). Subjects with telangiectasias and/or mild reticular veins will be eligible (CEAP C1)
  • Patients who have been prescribed compression stockings by a health care provider at any time in the past, aside from prophylactic use during prior hospitalization to prevent VTE
  • Patients who have undergone any procedure for treatment of lower extremity varicose veins, including: sclerotherapy, venous ablation, phlebectomy, or a stripping procedure
  • History of DVT or SVT
  • Pregnancy
  • Active malignancy
  • Documented hypercoagulable state
  • Body weight exceeds weight limit of the venous air plethysmograph chair equipment (approximately 375 lbs)
  • Clinical diagnosis of lower extremity peripheral arterial disease or abnormal ankle-brachial index (ABI) in either lower extremity
  • History of surgical intervention involving pelvis or lower extremities
  • Pelvic or lower extremity radiation
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554541
Dr Heather Gornik, Cleveland Clinic Foundation
07-617
The Cleveland Clinic
 
Principal Investigator: Heather Gornik, MD, RVT The Cleveland Clinic
The Cleveland Clinic
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP