Mechanisms Defending Fat Mass in Humans After Lipectomy

Not Applicable

Completed

• Conditions: Expanded Fat Pads; Disproportionate Shape
• Interventions: Other: Standard of Care without Liposuction; Procedure: Standard of Care with Liposuction

• Registration Number: NCT00993213
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study Start: 2004-04
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

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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*

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Liposuction	Standard of Care without Liposuction	Standard of Care without Liposuction'
Liposuction	Standard of Care with Liposuction	Standard of Care with Liposuction

Primary Outcome Measures

Name	Time	Method
Changes in body composition.	Baseline, 6wks, 6mos, 1-year	Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States