Eosinophils in Human Adipose Tissue

Role of Eosinophils in Human Adipose Tissue Metabolism

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Procedure: endoscopy sleeve gastroplasty

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with Obesity; 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; endoscopic procedure for weight loss

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elena Anna O. De Filippis, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Insulin Resistance
• Other Study ID Numbers: 21-000959

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No