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
  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:

  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

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
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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 August 20, 2014