Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
1 other identifier
interventional
24
1 country
1
Brief Summary
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
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
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 21, 2020
CompletedStudy Start
First participant enrolled
January 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedJanuary 19, 2022
January 1, 2022
2 years
January 15, 2020
January 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of eosinophils in adipose tissue
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
baseline
Secondary Outcomes (1)
Correlation between eosinophil content and body mass index (BMI)
baseline
Other Outcomes (1)
Quantification of the difference in gene methylation in eosinophils from lean and obese subjects
baseline
Study Arms (2)
Lean, Healthy Controls
ACTIVE COMPARATORSubjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected
Obese, Non-Diabetic
EXPERIMENTALSubject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Related Publications (1)
Hernandez JD, Li T, Ghannam H, Rau CM, Masuda MY, Madura JA 2nd, Jacobsen EA, De Filippis E. Linking adipose tissue eosinophils, IL-4, and leptin in human obesity and insulin resistance. JCI Insight. 2024 Feb 8;9(3):e170772. doi: 10.1172/jci.insight.170772.
PMID: 38206766DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena De Filippis, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 21, 2020
Study Start
January 29, 2020
Primary Completion
January 17, 2022
Study Completion
January 17, 2022
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share