Mechanisms Defending Fat Mass in Humans After Lipectomy

Study Overview
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Brief Summary
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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
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Specific Aims: To determine if suction lipectomy fails to modify regional and/or total body fat over three years. 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. 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.

Official Title
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Mechanisms Defending Fat Mass in Humans After Lipectomy

Conditions
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Disproportionate Shape, Expanded Fat Pads

Intervention / Treatment
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* Procedure: Standard of Care with Liposuction
* Other: Standard of Care without Liposuction


Participation Criteria
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Eligibility Criteria
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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: obesity and weight loss >10% of maximum body weight, or 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*

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposuction<br>Standard of Care with Liposuction | Procedure: Standard of Care with Liposuction<br>* Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.<br>|
| Sham Comparator: No Liposuction<br>Standard of Care without Liposuction' | Other: Standard of Care without Liposuction<br>* Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat mass, body composition