Eosinophils in Human Adipose Tissue

Study Overview
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Brief Summary
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The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance.

Official Title
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Role of Eosinophils in Human Adipose Tissue Metabolism

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Procedure: endoscopy sleeve gastroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity (BMI>30 kg/m2). Evidence of insulin resistance as defined by hemoglobin A1c > 5.7%. Mayo Clinic patients evaluated by Dr. Rahul Pannala. Pursue an endoscopic gastroplasty at Mayo Clinic Arizona in the Gastroenterology department. Equal distribution of gender. 18 yo older of age. BMI>30 kg/m2. Nonsmoker. Taking no medication affecting glucose or lipid metabolism. No more than 5% change in body weight in the previous 6 months. Mostly sedentary (engaging in strenuous exercise (> 70% max HR) less than 3 times a week). Not be receiving corticosteroid therapy. Have no history of asthma, COPD or atopic syndrome, or autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome). Exclusion Criteria: <17 years of age. BMI <30 kg/m2. Smoker. Taking medication affecting glucose or lipid metabolism. Greater than 5% change in body weight within the previous six months. Engage in strenuous exercise (>70% max HR) less than 3 times a week. Receiving corticosteroid therapy. Have a history of asthma. History of COPD or atopic syndrome. History of autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Obesity<br>Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure | Procedure: endoscopy sleeve gastroplasty<br>* endoscopic procedure for weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | total body weight | at 30 days post-intervention | 
| weight loss | total body weight | at 60 days post-intervention | 
| weight loss | total body weight | at 90 days post-intervention | 
| fat mass | % fat mass will be estimated by bioimpedence | at 30 days post-intervention | 
| fat mass | % fat mass will be estimated by bioimpedence | at 60 days post-intervention | 
| fat mass | % fat mass will be estimated by bioimpedence | at 90 days post-intervention | 
| AT-EOS content | subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells | at baseline | 
| AT-EOS content | subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells | at 90 days post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity | mixed meal test | at baseline and 90 days post-intervention | 
| inflammation | Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA | at 30 days post-intervention | 
| inflammation | Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA | at 60 days post-intervention | 
| inflammation | Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA | at 90 days post-intervention | 
| adipose tissue inflammation | subcutaneous fat biopsy will be processed to obtain mRNA. mRNA levels for MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin gene will be assessed via qPCR | at baseline | 
| adipose tissue inflammation | subcutaneous fat biopsy will be processed to obtain mRNA. mRNA levels for MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin gene will be assessed via qPCR | at 90 days post-intervention |