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Mechanisms Defending Fat Mass in Humans After Lipectomy

Mechanisms Defending Fat Mass in Humans After Lipectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00993213
Enrollment
32
Registered
2009-10-12
Start date
2004-04-30
Completion date
2008-11-30
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disproportionate Shape, Expanded Fat Pads

Keywords

fat mass, body composition

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 intervention to determine if adipose tissue is defended, and if so to determine the anatomic pattern of redistribution.

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.

Interventions

PROCEDUREStandard of Care with Liposuction

Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.

OTHERStandard of Care without Liposuction

Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.

Sponsors

Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories
CollaboratorUNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 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: 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\*

Design outcomes

Primary

MeasureTime frameDescription
Changes in body composition.Baseline, 6wks, 6mos, 1-yearChanges in body composition as measured by Dual X-ray Absorptiometry (DXA).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026