Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease

Obesity Clinical Trial

Official title:

Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00554541
• Other study ID #: 07-617
• Status: Terminated
• Phase: N/A
• First received: November 5, 2007
• Last updated: January 29, 2017
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Ankle Brachial Index Venous physiologic study
Assessment of lower extremity venous disease

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The purpose of this study is to investigate the reason for the relationship between body weight and higher risk of venous problems.		single time point