Following Lipectomy to Understand Adipose Tissue Re-accumulation (NCT00995631) | Clinical Trial Compass
CompletedNot Applicable
Following Lipectomy to Understand Adipose Tissue Re-accumulation
United States53 participantsStarted 2008-01
Plain-language summary
The typical female pattern of accumulating fat in the hips and thighs has long been thought to confer less risk for disease than the typical male abdominal fat pattern. However, leg fat may not simply be benign with respect to disease risk, but may in fact protect against cardiovascular disease risk. Although the mechanism for this is unknown, the investigators hypothesize that removing a portion of this important fat depot (via liposuction) could increase disease risk. Such unfavorable results may or may not be transient depending on an individual's ability to defend their fat mass. Because sex hormones appear to play a role in regional fat accumulation, the investigators hypothesize that estrogen-deficient postmenopausal women may have an augmented abdominal fat accumulation and an attenuated hip and thigh re-accumulation compared to premenopausal women following lipectomy and compared to non-surgical controls. As a result, the increased abdominal fat accumulation may worsen disease risk in postmenopausal women. Menopause-related differences in fat storage at baseline are also expected to determine the degree to which lipectomy alters disease risk and the propensity for AT re-accumulation.
Who can participate
Age range
35 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* post-menopausal (no menses for 12mo or oophorectomy w/ follicle-stimulating hormone (FSH)\>30 IU/L) OR- pre-menopausal (regular menses 28+/-3d)
* BMI \>20 and \<30 kg/m2)
* weight stable (+/- 2kg in past 2mo)
* non-smoking
* no use of hormone therapies or oral contraceptives
* actively seeking liposuction of the hips and thighs
* good femoral lipectomy candidates as determined by cosmetic surgeon
Exclusion Criteria:
* severe hypertriglyceridemia (\>400 mg/dL)
* medications known to affect lipid metabolism
* elevated resting blood pressure (Systolic \>140 mm Hg,Diastolic \>90 mm Hg)
* history of lipectomy or gastric bypass surgery
* body dysmorphic disorder
* pregnant, lactating or intention of becoming pregnant
* indication of high surgical risk (e.g., abnormal resting ECG, history of thromboembolism, valvular heart disease)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.