Back to resultsInvestigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Primary Purpose
Obese, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fat Tissue Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Obese
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lean, Healthy Controls
Obese, Non-Diabetic
Arm Description
Subjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected
Subject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected
Outcomes
Primary Outcome Measures
Number of eosinophils in adipose tissue
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
Secondary Outcome Measures
Correlation between eosinophil content and body mass index (BMI)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04234295
Brief Title
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Official Title
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lean, Healthy Controls
Arm Type
Active Comparator
Arm Description
Subjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected
Arm Title
Obese, Non-Diabetic
Arm Type
Experimental
Arm Description
Subject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected
Intervention Type
Procedure
Intervention Name(s)
Fat Tissue Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of eosinophils in adipose tissue
Description
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Correlation between eosinophil content and body mass index (BMI)
Description
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
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
Quantification of the difference in gene methylation in eosinophils from lean and obese subjects
Description
Gene methylation of eosinophils will be quantified in samples derived from lean and obese fat biopsy
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena De Filippis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
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