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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)
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00554541
First received: November 5, 2007
Last updated: February 2, 2009
Last verified: February 2009
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Heather Gornik, MD, RVT The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Dr Heather Gornik, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00554541     History of Changes
Other Study ID Numbers: 07-617
Study First Received: November 5, 2007
Last Updated: February 2, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Peripheral Arterial Disease
Peripheral Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013