Disproportionate ShapeNCT00993213
Mechanisms Defending Fat Mass in Humans After Lipectomy
A study of Disproportionate Shape and Expanded Fat Pads, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disproportionate Shape, Expanded Fat Pads
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
- obesity and weight loss >10% of maximum body weight, or
- liposuction or gastric bypass surgery;
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Disproportionate Shape, Expanded Fat Pads
- Being tested
- Standard of Care with Liposuction, Standard of Care without Liposuction
- Keywords
- fat mass, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care with LiposuctionProcedure or surgery
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.
Standard of Care without LiposuctionOther
Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.
| Study group | Role | What they receive |
|---|---|---|
| Liposuction | Active comparator | Standard of Care with Liposuction Receives: Procedure: Standard of Care with Liposuction |
| No Liposuction | Sham comparator | Standard of Care without Liposuction' Receives: Other: Standard of Care without Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition.
Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).
Measured: Baseline, 6wks, 6mos, 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startApr 2004
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disproportionate ShapeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Robert H Eckel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993213
- Sponsor's protocol ID
- 01-499
- Other IDs
- R01DK061668
- Status last verified
- Dec 2016
- First submitted
- 8 Oct 2009
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18070747Hernandez 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.
PubMed 21475140
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Defending Fat Mass in Humans After Lipectomy
- ClinicalTrials.gov ID
- NCT00993213
- Acronym / sponsor ID
- 01-499
- Conditions
- Disproportionate Shape, Expanded Fat Pads
- Keywords
- fat mass, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical Nutrition Research Unit-Metabolic and Energy Balance Laboratories, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposuction | Active comparator | Procedure: Standard of Care with LiposuctionStandard of Care with Liposuction |
| No Liposuction | Sham comparator | Other: Standard of Care without LiposuctionStandard of Care without Liposuction' |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care with LiposuctionStandard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery. | Procedure or surgery | Liposuction |
| Standard of Care without LiposuctionStandard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed. | Other | No Liposuction |
Primary outcome
Changes in body composition.
Time frame: Baseline, 6wks, 6mos, 1-year
Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 18070747Wu 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.
- Results publication: PubMed 21475140Hernandez 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Eckel, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Disproportionate Shape and Expanded Fat Pads, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition. (time frame: Baseline, 6wks, 6mos, 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.