Mechanisms Defending Fat Mass in Humans After Lipectomy

This study has been completed.
Sponsor:
Collaborators:
Colorado Clinical Nutrition Research Unit—Metabolic and Energy Balance Laboratories
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00993213
First received: October 8, 2009
Last updated: September 2, 2015
Last verified: September 2015
  Purpose
Liposuction surgery is common, yet animal and limited human data suggest that fat returns when removed. This study was designed as a 1-year randomized-controlled trial of suction lipectomy versus no intervention to determine if adipose tissue is defended, and if so to determine the anatomic pattern of redistribution.

Condition Intervention
Disproportionate Shape Created by Expanded Fat Pads.
Procedure: Standard of Care with Liposuction
Other: Standard of Care without Liposuction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms Defending Fat Mass in Humans After Lipectomy

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

Primary Outcome Measures:
  • Changes in body composition. [ Time Frame: Baseline, 6wks, 6mos, 1-year ] [ Designated as safety issue: No ]
    Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).


Enrollment: 32
Study Start Date: April 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liposuction
Standard of Care with Liposuction
Procedure: Standard of Care with Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.
Sham Comparator: No Liposuction
Standard of Care without Liposuction'
Other: Standard of Care without Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.

Detailed Description:

Specific Aims:

  1. To determine if suction lipectomy fails to modify regional and/or total body fat over three years.
  2. To determine if the expression of candidate genes predicts and/or relates to subcutaneous adipose tissue growth or depletion in subcutaneous adipose tissue after suction lipectomy.
  3. To examine adipose tissue before and after suction lipectomy to uncover novel genes where expression predicts and/or relates to subcutaneous adipose tissue growth or depletion after subcutaneous suction lipectomy.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible premenopausal women between the ages of 18-50 years;
  • BMI of 22-27 kg/m2 at the subjects maximum body weight;
  • Weight stable for at least 3 months (defined as a <5-7% change from the maximum weight over 3-6 months);
  • Non-smokers.

Exclusion Criteria:

  • Any history of glucose intolerance, dyslipidemia, liver, kidney and cardiac disease, hypertension, cancer or any other chronic debilitating disorder that might have interfered with a 'normal' lifestyle, e.g. nutrition, physical activity;
  • Thyroid hormone replacement with abnormal thyroid stimulating hormone (TSH) results;
  • Use of oral contraceptives if the subject did/could not remain on therapy throughout study participation.
  • Reduced-obese, defined as a history of:

    1. obesity and weight loss >10% of maximum body weight, or
    2. liposuction or gastric bypass surgery;
  • Evidence of body dysmorphic disorder;
  • Taking sex steroids, glucocorticoids, or medications affecting carbohydrate and lipid metabolism;
  • Hematocrit, hemoglobin, white blood cell count (WBC), platelet count, liver or renal function tests out of the normal range;
  • Fasting plasma glucose >110 mg/dL;
  • Triglycerides >200 mg/dL;
  • High density lipoprotein (HDL) cholesterol <35 mg/dL;
  • Low density lipoprotein (LDL) cholesterol >160 mg/dL;
  • Proteinuria;
  • Blood pressure >140/90 mm/Hg;
  • Electrocardiogram abnormalities;
  • History of claustrophobia;
  • Placement of metal implants*
  • History of internal metal fragments*

*Were evaluated by the radiologist prior to study determination*

  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: NCT00993213

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical Nutrition Research Unit—Metabolic and Energy Balance Laboratories
National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert H Eckel, MD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00993213     History of Changes
Other Study ID Numbers: 01-499  R01DK061668 
Study First Received: October 8, 2009
Last Updated: September 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
fat mass
body composition

ClinicalTrials.gov processed this record on August 25, 2016