Mechanisms Defending Fat Mass in Humans After Lipectomy
This study has been completed.
Sponsor:
Collaborators:
P30 DK-48520-01
M01-RR00051
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00993213
First received: October 8, 2009
Last updated: January 15, 2010
Last verified: January 2010
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Purpose
Liposuction surgery is common, yet animal and limited human data suggest that fat returns when removed. We undertook 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.
| Condition | Intervention |
|---|---|
|
Disproportionate Shape Created by Expanded Fat Pads. |
Procedure: Liposuction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mechanisms Defending Fat Mass in Humans After Lipectomy |
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- Body composition changes measured by DXA. [ Time Frame: Baseline, 6wks, 6mos, 1-year ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | April 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liposuction
Liposuction surgery
|
Procedure: Liposuction
Liposuction surgery
|
|
No Intervention: Control
No intervention.
|
Procedure: Liposuction
Liposuction surgery
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Eligible premenopausal women were between the ages of 18-50 years with a BMI of 22-27 kg/m2 at their maximum body weight and weight stable for at least 3 months. Weight stability was defined as a <5-7% change from the maximum weight over 3-6 months. In addition, participants were non-smokers with no 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 (nutrition, physical activity). Women on thyroid hormone replacement with a normal TSH were included. Oral contraceptives were acceptable if the woman remained on therapy throughout study participation.
Exclusion Criteria:
- Further exclusions included: reduced-obese, defined as history of obesity and weight loss >10% of maximum body weight, or of liposuction or gastric bypass surgery; evidence of body dysmorphic disorder; taking sex steroids, glucocorticoids, or medications affecting carbohydrate and lipid metabolism; hematocrit, hemoglobin, WBC, platelet count, liver or renal function tests out of the normal range; fasting plasma glucose >110 mg/dL; triglycerides >200 mg/dL; HDL cholesterol <35 mg/dL and LDL cholesterol >160 mg/dL; proteinuria; blood pressure >140/90 mm/Hg; electrocardiogram abnormalities. People with a history of claustrophobia, or who had any placement of metal implants or a history of internal metal fragments were evaluated by the radiologist prior to inclusion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993213
Locations
| United States, Colorado | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
P30 DK-48520-01
M01-RR00051
Investigators
| Principal Investigator: | Robert H Eckel, MD | University of Colorado, Denver |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robert H. Eckel, MD; Professor of Medicine, Univeristy of Colorado Denver |
| ClinicalTrials.gov Identifier: | NCT00993213 History of Changes |
| Other Study ID Numbers: | DK61668 (completed), R01DK-061668 |
| Study First Received: | October 8, 2009 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
fat mass body composition |
ClinicalTrials.gov processed this record on June 18, 2013