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Completed

NCT Number: NCT04898400

Eosinophils in Human Adipose Tissue

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

endoscopy sleeve gastroplasty

Procedure

endoscopic procedure for weight loss

Primary outcomes

  1. weight loss

    Time frame: at 30 days post-intervention

    total body weight

  2. weight loss

    Time frame: at 60 days post-intervention

    total body weight

  3. weight loss

    Time frame: at 90 days post-intervention

    total body weight

  4. fat mass

    Time frame: at 30 days post-intervention

    % fat mass will be estimated by bioimpedence

  5. fat mass

    Time frame: at 60 days post-intervention

    % fat mass will be estimated by bioimpedence

  6. fat mass

    Time frame: at 90 days post-intervention

    % fat mass will be estimated by bioimpedence

  7. AT-EOS content

    Time frame: at baseline

    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

  8. AT-EOS content

    Time frame: 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

Secondary outcomes

  1. insulin sensitivity

    Time frame: at baseline and 90 days post-intervention

    mixed meal test

  2. inflammation

    Time frame: at 30 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

  3. inflammation

    Time frame: at 60 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

  4. inflammation

    Time frame: 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

  5. adipose tissue inflammation

    Time frame: at baseline

    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

  6. adipose tissue inflammation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Role of Eosinophils in Human Adipose Tissue Metabolism

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2021
Registry last updated
Jan 28, 2026

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.

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