Mechanisms Defending Fat Mass in Humans After Lipectomy

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Expanded Fat Pads; Disproportionate Shape

Treatments: Other: Standard of Care without Liposuction; Procedure: Standard of Care with Liposuction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00993213

R01DK061668 (U.S. NIH Grant/Contract)

01-499

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Liposuction

Active Comparator group

Description:

Standard of Care with Liposuction

Treatment:

Procedure: Standard of Care with Liposuction

No Liposuction

Sham Comparator group

Description:

Standard of Care without Liposuction'

Treatment:

Other: Standard of Care without Liposuction