Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease - Full Text View

Purpose

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.

Condition

Obesity
Peripheral Arterial Disease

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	45
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)

Groups/Cohorts

1

Normal Body-Mass Index: 18.5-24.9

2

Obese Body-Mass Index: 30.0-39.9

3

Morbidly Obese Body-Mass Index: ≥ 40

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients of the Cleveland Clinic Foundation.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554541

Contacts


Contact: Abizer Sakarwala, BS	(216) 444-0334	sakarwa@ccf.org

Contact: Meisam Moghbelli, MD	(216) 444-0334	moghbem@ccf.org

Locations


United States, Ohio
	Cleveland Clinic Foundation	Recruiting
	Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	Heather Gornik, MD, RVT	The Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic Foundation ( Dr Heather Gornik )
Study ID Numbers:	07-617
First Received:	November 5, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00554541
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Peripheral Vascular Diseases

Vascular Diseases

Nutrition Disorders

Overweight

Overnutrition

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00554541