Status:
COMPLETED
Mechanisms Defending Fat Mass in Humans After Lipectomy
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Disproportionate Shape
Expanded Fat Pads
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 i...
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 su...
Eligibility Criteria
Inclusion
- 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
- 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\*
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00993213
Start Date
April 1 2004
End Date
November 1 2008
Last Update
December 6 2016
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045