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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Peripheral Arterial Disease
• Intervention / Treatment: Other: Ankle Brachial Index Venous physiologic study

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cleveland Clinic Foundation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Body-Mass; BMI Index: 18.5-24.9 Ankle Brachial Index Venous physiologic study	Other: Ankle Brachial Index Venous physiologic study; Assessment of lower extremity venous disease; Other Names: ABI
Obese Body-Mass; BMI Index: 30.0-39.9 Ankle Brachial Index Venous physiologic study	Other: Ankle Brachial Index Venous physiologic study; Assessment of lower extremity venous disease; Other Names: ABI
Morbidly Obese Body-Mass; BMI Index: ≥ 40 Ankle Brachial Index Venous physiologic study	Other: Ankle Brachial Index Venous physiologic study; Assessment of lower extremity venous disease; Other Names: ABI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Heather Gornik, MD, RVT, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: November 5, 2007
• First Submitted That Met QC Criteria: November 6, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 07-617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No