Mechanisms Defending Fat Mass in Humans After Lipectomy
NCT ID: NCT00993213
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2004-04-30
2008-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liposuction
Standard of Care with Liposuction
Standard of Care with Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.
No Liposuction
Standard of Care without Liposuction'
Standard of Care without Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.
Interventions
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Standard of Care with Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.
Standard of Care without Liposuction
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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\*
18 Years
50 Years
FEMALE
Yes
Sponsors
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Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories
UNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Robert H Eckel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver
Aurora, Colorado, United States
Countries
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References
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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.
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.
Other Identifiers
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01-499
Identifier Type: -
Identifier Source: org_study_id