Following Lipectomy to Understand Adipose Tissue Re-accumulation (FLARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00995631
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment Phase
Menopause Pre-menopause Procedure: Femoral lipectomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Regional Fat Re-accumulation Following Lipectomy in Pre- and Post-menopausal Women
Study Start Date : January 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
No Intervention: Premenopausal, Control
Premenopausal women randomized to Control (delayed liposuction surgery)
Active Comparator: Premenopausal, Surgery
Premenopausal women randomized to surgery (femoral lipectomy)
Procedure: Femoral lipectomy
Standard (non-experimental) suction assisted liposuction surgery

No Intervention: Postmenopausal, Control
Postmenopausal women randomized to Control (delayed liposuction surgery)
Active Comparator: Postmenopausal, Surgery
Postmenopausal women randomized to surgery (femoral lipectomy)
Procedure: Femoral lipectomy
Standard (non-experimental) suction assisted liposuction surgery

Primary Outcome Measures :
  1. Postprandial triglyceride excursions (incremental areas) [ Time Frame: Baseline, 2Mo, and 14Mo ]
  2. Abdominal and femoral fat mass accumulation [ Time Frame: Baseline, 2Mo, and 14Mo ]

Secondary Outcome Measures :
  1. Triglyceride storage (14C-oleic acid incorporation into abdominal and femoral adipose tissue) [ Time Frame: Baseline, 2Mo, and 14Mo ]
  2. Lipoprotein lipase activity (abdominal and femoral adipose tissue) [ Time Frame: Baseline, 2Mo, and 14Mo ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00995631

United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Rachael E Van Pelt, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00995631     History of Changes
Other Study ID Numbers: 07-0339
NIH DK077992
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by University of Colorado, Denver:
adipose tissue
dietary fatty acids
triglyceride storage
Normal healthy aging