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CompletedNCT04898400Updated Jan 28, 2026

Eosinophils in Human Adipose Tissue

An interventional study of endoscopy sleeve gastroplasty in Obesity and Insulin Resistance, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Insulin Resistance
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 4 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

Interventions

  • Procedureendoscopy sleeve gastroplasty

    endoscopic procedure for weight loss

06

What researchers measure

Primary outcomes

  1. weight loss

    total body weight

    Time frame: at 30 days post-intervention

  2. weight loss

    total body weight

    Time frame: at 60 days post-intervention

  3. weight loss

    total body weight

    Time frame: at 90 days post-intervention

  4. fat mass

    % fat mass will be estimated by bioimpedence

    Time frame: at 30 days post-intervention

  5. fat mass

    % fat mass will be estimated by bioimpedence

    Time frame: at 60 days post-intervention

  6. fat mass

    % fat mass will be estimated by bioimpedence

    Time frame: at 90 days post-intervention

  7. 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

    Time frame: at baseline

  8. 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

    Time frame: at 90 days post-intervention

Secondary outcomes

  1. insulin sensitivity

    mixed meal test

    Time frame: at baseline and 90 days post-intervention

  2. inflammation

    Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA

    Time frame: at 30 days post-intervention

  3. inflammation

    Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA

    Time frame: at 60 days post-intervention

  4. inflammation

    Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA

    Time frame: at 90 days post-intervention

  5. 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

    Time frame: at baseline

  6. 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

    Time frame: at 90 days post-intervention

07

Study locations

1 site
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04898400
Lead sponsor
Mayo Clinic
Responsible party
Elena Anna (Eleanna) De Filippis, M.D., Ph.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 24, 2021
Start date
Jun 1, 2021
Primary completion
Aug 26, 2022
Completion
Aug 26, 2022
Last update
Jan 28, 2026

Study contacts

Elena Anna O. De Filippis, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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