Immune Characterization of Subcutaneous Adipose Tissue (ATI)

September 6, 2017 updated by: Washington University School of Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Weight (BMI: 18.5-24.9 kg/m²)
Liposuction/lipectomy
Procedure: Liposuction/lipectomy
Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells
Overweight (BMI: 25.0-29.9 kg/m²)
Liposuction/lipectomy
Procedure: Liposuction/lipectomy
Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells
Obese (BMI: >30.0kg/m²)
Liposuction/lipectomy
Procedure: Liposuction/lipectomy
Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2014

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-02113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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