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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Colorado, Denver.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00995631
First received: October 12, 2009
Last updated: January 15, 2013
Last verified: October 2009
  Purpose

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 Intervention
Menopause
Pre-menopause
Procedure: Femoral lipectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Regional Fat Re-accumulation Following Lipectomy in Pre- and Post-menopausal Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Postprandial triglyceride excursions (incremental areas) [ Time Frame: Baseline, 2Mo, and 14Mo ] [ Designated as safety issue: No ]
  • Abdominal and femoral fat mass accumulation [ Time Frame: Baseline, 2Mo, and 14Mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Triglyceride storage (14C-oleic acid incorporation into abdominal and femoral adipose tissue) [ Time Frame: Baseline, 2Mo, and 14Mo ] [ Designated as safety issue: No ]
  • Lipoprotein lipase activity (abdominal and femoral adipose tissue) [ Time Frame: Baseline, 2Mo, and 14Mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995631

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00995631     History of Changes
Other Study ID Numbers: 07-0339, NIH DK077992
Study First Received: October 12, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014