NCT04898400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

May 16, 2021

Last Update Submit

January 26, 2026

Conditions

ObesityInsulin Resistance

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (6)

  • insulin sensitivity

    at baseline and 90 days post-intervention

  • inflammation

    at 30 days post-intervention

  • inflammation

    at 60 days post-intervention

  • inflammation

    at 90 days post-intervention

  • adipose tissue inflammation

    at baseline

  • +1 more secondary outcomes

Study Arms (1)

Subjects with Obesity

EXPERIMENTAL

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

endoscopy sleeve gastroplastyPROCEDURE

endoscopic procedure for weight loss

Subjects with Obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • \<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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Elena Anna O. De Filippis, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 24, 2021

Study Start

June 1, 2021

Primary Completion

August 26, 2022

Study Completion

August 26, 2022

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)