Clinical trial NCT00993213: Mechanisms Defending Fat Mass in Humans After Lipectomy
Official title: Mechanisms Defending Fat Mass in Humans After Lipectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disproportionate Shape
Expanded Fat Pads
Keywords: fat mass
body composition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-10-12
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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\*

Primary outcomes:
measure: Changes in body composition.
timeFrame: Baseline, 6wks, 6mos, 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert H Eckel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu X, Zvonic S, Floyd ZE, Kilroy G, Goh BC, Hernandez TL, Eckel RH, Mynatt RL, Gimble JM. Induction of circadian gene expression in human subcutaneous adipose-derived stem cells. Obesity (Silver Spring). 2007 Nov;15(11):2560-70. doi: 10.1038/oby.2007.308.
citation: Hernandez TL, Kittelson JM, Law CK, Ketch LL, Stob NR, Lindstrom RC, Scherzinger A, Stamm ER, Eckel RH. Fat redistribution following suction lipectomy: defense of body fat and patterns of restoration. Obesity (Silver Spring). 2011 Jul;19(7):1388-95. doi: 10.1038/oby.2011.64. Epub 2011 Apr 7.