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OpenTrials
Completed

NCT Number: NCT02076087

Immune Characterization of Subcutaneous Adipose Tissue

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.

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Key information

Conditions

Determine Immune Cell Types in Subcutaneous Adipose Tissue

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposuction/lipectomy

Procedure

Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells

Primary outcomes

  1. 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

Secondary outcomes

  1. Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: ATI

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2014
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.