ObesityNCT00554541
Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
An observational study of Obesity and Peripheral Arterial Disease, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Peripheral Arterial Disease
- What is being tested?
- Ankle Brachial Index Venous physiologic study
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients of the Cleveland Clinic Foundation.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Peripheral Arterial Disease
- Being tested
- Ankle Brachial Index Venous physiologic study
- Medical subject headings
- Obesity, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Brachial Index Venous physiologic studyOther
Also called ABI
Assessment of lower extremity venous disease
| Study group | Role | What they receive |
|---|---|---|
| Normal Body-Mass | BMI Index: 18.5-24.9 Ankle Brachial Index Venous physiologic study Receives: Other: Ankle Brachial Index Venous physiologic study | |
| Obese Body-Mass | BMI Index: 30.0-39.9 Ankle Brachial Index Venous physiologic study Receives: Other: Ankle Brachial Index Venous physiologic study | |
| Morbidly Obese Body-Mass | BMI Index: ≥ 40 Ankle Brachial Index Venous physiologic study Receives: Other: Ankle Brachial Index Venous physiologic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to investigate the reason for the relationship between body weight and higher risk of venous problems.
Measured: single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionJan 2009
Why it stopped: Lack of study subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Gornik, The Cleveland Clinic
- Investigators
- Heather Gornik, MD, RVT, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554541
- Sponsor's protocol ID
- 07-617
- Status last verified
- Jan 2017
- First submitted
- 5 Nov 2007
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
- ClinicalTrials.gov ID
- NCT00554541
- Acronym / sponsor ID
- 07-617
- Conditions
- Obesity, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of study subjects
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Body-Mass | – | Other: Ankle Brachial Index Venous physiologic studyBMI Index: 18.5-24.9 Ankle Brachial Index Venous physiologic study |
| Obese Body-Mass | – | Other: Ankle Brachial Index Venous physiologic studyBMI Index: 30.0-39.9 Ankle Brachial Index Venous physiologic study |
| Morbidly Obese Body-Mass | – | Other: Ankle Brachial Index Venous physiologic studyBMI Index: ≥ 40 Ankle Brachial Index Venous physiologic study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients of the Cleveland Clinic Foundation.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle Brachial Index Venous physiologic studyAlso: ABIAssessment of lower extremity venous disease | Other | Morbidly Obese Body-Mass, Normal Body-Mass, Obese Body-Mass |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of study subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Gornik, MD, RVT principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Peripheral Arterial Disease, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of study subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.