Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue

January 17, 2022 updated by: Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ages 30-50 years
  • Non-smokers
  • Lean subjects with a BMI of 25 or less, gender specific normal body fat,
  • Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism
  • subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery

Exclusion Criteria:

  • Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome
  • taking any biologic treatment for any autoimmune disorder
  • Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lean, Healthy Controls
Subjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected
Procedure: Fat Tissue Biopsy
If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.
EXPERIMENTAL: Obese, Non-Diabetic
Subject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected
Procedure: Fat Tissue Biopsy
If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of eosinophils in adipose tissue
Time Frame: baseline
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between eosinophil content and body mass index (BMI)
Time Frame: baseline
Measured as a linear regression between BMI (defined as the weight in Kg/height in square m; kg/m2) and eosinophil number in the fat
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the difference in gene methylation in eosinophils from lean and obese subjects
Time Frame: baseline
Gene methylation of eosinophils will be quantified in samples derived from lean and obese fat biopsy
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Elena De Filippis, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2020

Primary Completion (ACTUAL)

January 17, 2022

Study Completion (ACTUAL)

January 17, 2022

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (ACTUAL)

January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-003803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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