Determine Immune Cell Types in Subcutaneous Adipose TissueATINCT02076087
Immune Characterization of Subcutaneous Adipose Tissue
An observational study of Determine Immune Cell Types in Subcutaneous Adipose Tissue, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall goal of this proposal is to characterize the immune cell profile of subcutaneous abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate potential associations between different adipose tissue immune cell types and metabolic profile. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Determine Immune Cell Types in Subcutaneous Adipose Tissue
- What is being tested?
- Liposuction/lipectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2017
- Phase
- Observational
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 women already scheduled to undergo liposcution/lipectomy procedure for breast reconstruction associated with prophylactic mastectomy or mastectomy for in situ ductal breast corcinoma, cosmetic surgery, or abdominal lipectomy for severe obesity at either Barnes-Jewish Hospital or Barnes-Jewish West County Hospital. Subjects of all races and ethnicity, with a body mass index (BMI) greater than or equal to 18.5 kg/m² and between the ages of 18 and 65 years of age will be included in the study.
Who may be able to join
- Women of all races and ethnicity
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥ 18.5 kg/m²
- Weight stable (+/- 3% during the last 2 months before enrollment)
- Women already scheduled for above mentioned procedures
Who cannot join
- Diabetes Mellitus
- Recent (<5 years) history of cancer (except in situ ductal breast carcinoma)
- Chemotherapy and/or radiation therapy within 4 months before enrollment
- Immune system diseases (i.e., autoimmune disorders, acquired immunodeficiency syndrome)
- Pregnant or breastfeeding
- Take any medication that might affect immune function
- Severe organ dysfunction
- BMI <18.5 kg/m² or size of each breast is >600 grams, if scheduled for bilateral breast reconstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The overall goal of this proposal is to characterize the immune cell profile of subcutaneous abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate potential associations between different adipose tissue immune cell types and metabolic profile.
- Being tested
- Liposuction/lipectomy
- Keywords
- Subcutaneous adipose tissue, Lipectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposuction/lipectomyProcedure or surgery
Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight (BMI: 18.5-24.9 kg/m²) | Liposuction/lipectomy Receives: Procedure: Liposuction/lipectomy | |
| Overweight (BMI: 25.0-29.9 kg/m²) | Liposuction/lipectomy Receives: Procedure: Liposuction/lipectomy | |
| Obese (BMI: >30.0kg/m²) | Liposuction/lipectomy Receives: Procedure: Liposuction/lipectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the types of immune cells and the relative prevalence of each type and sub-type, in subcutaneous adipose tissue of normal weight, overweight, obese and lipedema adults.
Measured: intraoperative
Secondary outcomes (1)
Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine Immune Cell Types in Subcutaneous Adipose TissueStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076087
- Sponsor's protocol ID
- 2013-02113
- Acronym
- ATI
- Status last verified
- Sep 2017
- First submitted
- 27 Feb 2014
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Characterization of Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT02076087
- Acronym / sponsor ID
- ATI / 2013-02113
- Keywords
- Subcutaneous adipose tissue, Lipectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Mar 2014 (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.
The overall goal of this proposal is to characterize the immune cell profile of subcutaneous abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate potential associations between different adipose tissue immune cell types and metabolic profile.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Weight (BMI: 18.5-24.9 kg/m²) | – | Procedure: Liposuction/lipectomyLiposuction/lipectomy |
| Overweight (BMI: 25.0-29.9 kg/m²) | – | Procedure: Liposuction/lipectomyLiposuction/lipectomy |
| Obese (BMI: >30.0kg/m²) | – | Procedure: Liposuction/lipectomyLiposuction/lipectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 women already scheduled to undergo liposcution/lipectomy procedure for breast reconstruction associated with prophylactic mastectomy or mastectomy for in situ ductal breast corcinoma, cosmetic surgery, or abdominal lipectomy for severe obesity at either Barnes-Jewish Hospital or Barnes-Jewish West County Hospital. Subjects of all races and ethnicity, with a body mass index (BMI) greater than or equal to 18.5 kg/m² and between the ages of 18 and 65 years of age will be included in the study.
Key inclusion criteria (5 listed)
- Women of all races and ethnicity
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥ 18.5 kg/m²
- Weight stable (+/- 3% during the last 2 months before enrollment)
- Women already scheduled for above mentioned procedures
Key exclusion criteria (8 listed)
- Diabetes Mellitus
- Recent (<5 years) history of cancer (except in situ ductal breast carcinoma)
- Chemotherapy and/or radiation therapy within 4 months before enrollment
- Immune system diseases (i.e., autoimmune disorders, acquired immunodeficiency syndrome)
- Pregnant or breastfeeding
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 |
|---|---|---|
| Liposuction/lipectomySubcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells | Procedure or surgery | Normal Weight (BMI: 18.5-24.9 kg/m²), Obese (BMI: >30.0kg/m²), Overweight (BMI: 25.0-29.9 kg/m²) |
Primary outcome
Determine the types of immune cells and the relative prevalence of each type and sub-type, in subcutaneous adipose tissue of normal weight, overweight, obese and lipedema adults.
Time frame: intraoperative
1 secondary outcome
Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.
Time frame: Baseline
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 7 Sep 2017.
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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determine Immune Cell Types in Subcutaneous Adipose Tissue, run by Washington University School of Medicine 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 5 inclusion and 8 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 7 Sep 2017. 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. 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?
Determine the types of immune cells and the relative prevalence of each type and sub-type, in subcutaneous adipose tissue of normal weight, overweight, obese and lipedema adults. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2017.