Immune Characterization of Subcutaneous Adipose Tissue

Completed

• Conditions: Determine Immune Cell Types in Subcutaneous Adipose Tissue
• Interventions: Procedure: Liposuction/lipectomy

• Registration Number: NCT02076087
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Weight (BMI: 18.5-24.9 kg/m²)	Liposuction/lipectomy	Liposuction/lipectomy
Overweight (BMI: 25.0-29.9 kg/m²)	Liposuction/lipectomy	Liposuction/lipectomy
Obese (BMI: >30.0kg/m²)	Liposuction/lipectomy	Liposuction/lipectomy

Primary Outcome Measures

Name	Time	Method
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.	intraoperative

Secondary Outcome Measures

Name	Time	Method
Determine the relationships among specific types and subtypes of immune cells, adiposity and cardiometabolic risk.	Baseline

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States