Eosinophils in Human Adipose Tissue

Not Applicable

• Conditions: Insulin Resistance; Obesity
• Interventions: Procedure: endoscopy sleeve gastroplasty

• Registration Number: NCT04898400
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Study Start: 2021-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 12

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with Obesity	endoscopy sleeve gastroplasty	Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure

Primary Outcome Measures

Name	Time	Method
AT-EOS content	at 90 days post-intervention	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
weight loss	at 90 days post-intervention	total body weight
fat mass	at 90 days post-intervention	% fat mass will be estimated by bioimpedence

Secondary Outcome Measures

Name	Time	Method
insulin sensitivity	at baseline and 90 days post-intervention	mixed meal test
inflammation	at 90 days post-intervention	Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
adipose tissue inflammation	at 90 days post-intervention	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

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States