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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK061668 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories | UNKNOWN |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposuction | Active Comparator | Standard of Care with Liposuction |
|
| No Liposuction | Sham Comparator | Standard of Care without Liposuction' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care with Liposuction | Procedure | Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery. |
|
| 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 |
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Inclusion Criteria:
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:
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*
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Eckel, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18070747 | Background | 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. | |
| 21475140 | Result | 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. |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care without Liposuction | Other | Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed. |
|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |