NCT00995631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

5.6 years

First QC Date

October 12, 2009

Last Update Submit

January 10, 2017

Conditions

MenopausePre-menopause

Keywords

liposuctionadipose tissuedietary fatty acidstriglyceride storageNormal healthy aging

Outcome Measures

Primary Outcomes (2)

  • Postprandial triglyceride excursions (incremental areas)

    Baseline, 2Mo, and 14Mo

  • Abdominal and femoral fat mass accumulation

    Baseline, 2Mo, and 14Mo

Secondary Outcomes (2)

  • Triglyceride storage (14C-oleic acid incorporation into abdominal and femoral adipose tissue)

    Baseline, 2Mo, and 14Mo

  • Lipoprotein lipase activity (abdominal and femoral adipose tissue)

    Baseline, 2Mo, and 14Mo

Study Arms (4)

Premenopausal, Control

NO INTERVENTION

Premenopausal women randomized to Control (delayed liposuction surgery)

Premenopausal, Surgery

ACTIVE COMPARATOR

Premenopausal women randomized to surgery (femoral lipectomy)

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)

Procedure: Femoral lipectomy

Interventions

Femoral lipectomyPROCEDURE

Standard (non-experimental) suction assisted liposuction surgery

Postmenopausal, SurgeryPremenopausal, Surgery

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Study Officials

  • Rachael E Van Pelt, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2009

First Posted

October 15, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2013

Study Completion

December 1, 2014

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

US(1)