Mechanisms Defending Fat Mass in Humans After Lipectomy

December 2, 2016 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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*

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition.
Time Frame: Baseline, 6wks, 6mos, 1-year
Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).
Baseline, 6wks, 6mos, 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories

Investigators

  • Principal Investigator: Robert H Eckel, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01-499
  • R01DK061668 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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