MenopauseFLARENCT00995631
Following Lipectomy to Understand Adipose Tissue Re-accumulation
A study testing Femoral lipectomy in people with Menopause and Pre-menopause, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Pre-menopause
- What is being tested?
- Femoral lipectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2014
- Phase
- Interventional
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Regional Fat Re-accumulation Following Lipectomy in Pre- and Post-menopausal Women
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.
Read the detailed description
Lipectomy is the most frequently performed aesthetic surgery in the U.S. today and is considered permanent, by The American Society for Aesthetic Plastic Surgery, but no long term follow-up studies have been done to verify this assertion. Indeed, animal studies suggest rapid adipose tissue (AT) re-accumulation after lipectomy is common and may even be accompanied by unfavorable changes in disease risk. Recent studies in humans have focused on abdominal lipectomy as a means of reducing metabolic disease risk in obese premenopausal women. However, none of these studies evaluated AT re-accumulation or reported long-term (>6 mo) changes in metabolic outcomes, and none have evaluated the effect of removing femoral AT despite this being a common site for lipectomy in women and despite the apparent cardioprotective benefit of lower body adiposity. Further, none of these studies included postmenopausal women who are at an increased risk of abdominal AT accumulation. It is the investigator's overall working hypothesis that removal of femoral AT by lipectomy may worsen metabolic disease risk (as measured by postprandial lipemia) in estrogen-deficient postmenopausal women who, in contrast to premenopausal women, will accumulate AT in the abdominal rather than the femoral region. The global aims of this study are to determine whether: 1) there are menopause-related differences in regional (abdominal vs. femoral) AT re-accumulation following lipectomy; and 2) changes (removal and regain) in femoral AT mass alter postprandial triglyceride clearance and storage of meal-derived fatty acids. Further, the investigators postulate that menopause-related differences in postprandial lipemia and handling of dietary fatty acids will determine the degree to which femoral lipectomy worsens these parameters. Pre- and postmenopausal women (n=80) will be randomly assigned to either femoral lipectomy or control (no surgery). All eligible volunteers will undergo testing at the beginning of the study and at 2, 8, and 14 months following lipectomy. Measurements will include body composition assessments, meal tests and AT biopsies to assess lipectomy-related changes in: 1) abdominal and femoral fat mass; 2) systemic postprandial triglyceride excursions; and 3) storage of dietary fatty acids in AT. These studies are designed to evaluate the effect of femoral lipectomy on regional AT re-accumulation and metabolic disease risk in pre- and postmenopausal women.
- Conditions
- Menopause, Pre-menopause
- Being tested
- Femoral lipectomy
- Keywords
- liposuction, adipose tissue, dietary fatty acids, triglyceride storage, Normal healthy aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral lipectomyProcedure or surgery
Standard (non-experimental) suction assisted liposuction surgery
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal, Control | No intervention | Premenopausal women randomized to Control (delayed liposuction surgery) |
| Premenopausal, Surgery | Active comparator | Premenopausal women randomized to surgery (femoral lipectomy) Receives: Procedure: Femoral lipectomy |
| Postmenopausal, Control | No intervention | Postmenopausal women randomized to Control (delayed liposuction surgery) |
| Postmenopausal, Surgery | Active comparator | Postmenopausal women randomized to surgery (femoral lipectomy) Receives: Procedure: Femoral lipectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglyceride excursions (incremental areas)
Measured: Baseline, 2Mo, and 14Mo
Abdominal and femoral fat mass accumulation
Measured: Baseline, 2Mo, and 14Mo
Secondary outcomes (2)
Triglyceride storage (14C-oleic acid incorporation into abdominal and femoral adipose tissue)
Measured: Baseline, 2Mo, and 14Mo
Lipoprotein lipase activity (abdominal and femoral adipose tissue)
Measured: Baseline, 2Mo, and 14Mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachael E Van Pelt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995631
- Sponsor's protocol ID
- 07-0339
- Other IDs
- NIH DK077992
- Acronym
- FLARE
- Status last verified
- Jan 2017
- First submitted
- 12 Oct 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Fat Re-accumulation Following Lipectomy in Pre- and Post-menopausal Women
- ClinicalTrials.gov ID
- NCT00995631
- Acronym / sponsor ID
- FLARE / 07-0339
- Conditions
- Menopause, Pre-menopause
- Keywords
- liposuction, adipose tissue, dietary fatty acids, triglyceride storage, Normal healthy aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Oct 2009 (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.
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.
Detailed description
Lipectomy is the most frequently performed aesthetic surgery in the U.S. today and is considered permanent, by The American Society for Aesthetic Plastic Surgery, but no long term follow-up studies have been done to verify this assertion. Indeed, animal studies suggest rapid adipose tissue (AT) re-accumulation after lipectomy is common and may even be accompanied by unfavorable changes in disease risk. Recent studies in humans have focused on abdominal lipectomy as a means of reducing metabolic disease risk in obese premenopausal women. However, none of these studies evaluated AT re-accumulation or reported long-term (>6 mo) changes in metabolic outcomes, and none have evaluated the effect of removing femoral AT despite this being a common site for lipectomy in women and despite the apparent cardioprotective benefit of lower body adiposity. Further, none of these studies included postmenopausal women who are at an increased risk of abdominal AT accumulation. It is the investigator's overall working hypothesis that removal of femoral AT by lipectomy may worsen metabolic disease risk (as measured by postprandial lipemia) in estrogen-deficient postmenopausal women who, in contrast to premenopausal women, will accumulate AT in the abdominal rather than the femoral region. The global aims of this study are to determine whether: 1) there are menopause-related differences in regional (abdominal vs. femoral) AT re-accumulation following lipectomy; and 2) changes (removal and regain) in femoral AT mass alter postprandial triglyceride clearance and storage of meal-derived fatty acids. Further, the investigators postulate that menopause-related differences in postprandial lipemia and handling of dietary fatty acids will determine the degree to which femoral lipectomy worsens these parameters. Pre- and postmenopausal women (n=80) will be randomly assigned to either femoral lipectomy or control (no surgery). All eligible volunteers will undergo testing at the beginning of the study and at 2, 8, and 14 months following lipectomy. Measurements will include body composition assessments, meal tests and AT biopsies to assess lipectomy-related changes in: 1) abdominal and femoral fat mass; 2) systemic postprandial triglyceride excursions; and 3) storage of dietary fatty acids in AT. These studies are designed to evaluate the effect of femoral lipectomy on regional AT re-accumulation and metabolic disease risk in pre- and postmenopausal women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Premenopausal, Control | No intervention | –Premenopausal women randomized to Control (delayed liposuction surgery) |
| Premenopausal, Surgery | Active comparator | Procedure: Femoral lipectomyPremenopausal women randomized to surgery (femoral lipectomy) |
| Postmenopausal, Control | No intervention | –Postmenopausal women randomized to Control (delayed liposuction surgery) |
| Postmenopausal, Surgery | Active comparator | Procedure: Femoral lipectomyPostmenopausal women randomized to surgery (femoral lipectomy) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Femoral lipectomyStandard (non-experimental) suction assisted liposuction surgery | Procedure or surgery | Postmenopausal, Surgery, Premenopausal, Surgery |
Primary outcome
Postprandial triglyceride excursions (incremental areas)
Time frame: Baseline, 2Mo, and 14Mo
Abdominal and femoral fat mass accumulation
Time frame: Baseline, 2Mo, and 14Mo
2 secondary outcomes
Triglyceride storage (14C-oleic acid incorporation into abdominal and femoral adipose tissue)
Time frame: Baseline, 2Mo, and 14Mo
Lipoprotein lipase activity (abdominal and femoral adipose tissue)
Time frame: Baseline, 2Mo, and 14Mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Rachael E Van Pelt, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral lipectomy in people with Menopause and Pre-menopause, run by University of Colorado, Denver 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 11 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postprandial triglyceride excursions (incremental areas) (time frame: Baseline, 2Mo, and 14Mo). The study lists 2 primary outcomes in all. 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 11 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.