Back to resultsEosinophils in Human Adipose Tissue
Primary Purpose
Obesity, Insulin Resistance
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endoscopy sleeve gastroplasty
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
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:
- <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).
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Obesity
Arm Description
Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure
Outcomes
Primary Outcome Measures
weight loss
total body weight
weight loss
total body weight
weight loss
total body weight
fat mass
% fat mass will be estimated by bioimpedence
fat mass
% fat mass will be estimated by bioimpedence
fat mass
% fat mass will be estimated by bioimpedence
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-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
Secondary Outcome Measures
insulin sensitivity
mixed meal test
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898400
Brief Title
Eosinophils in Human Adipose Tissue
Official Title
Role of Eosinophils in Human Adipose Tissue Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Obesity
Arm Type
Experimental
Arm Description
Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure
Intervention Type
Procedure
Intervention Name(s)
endoscopy sleeve gastroplasty
Intervention Description
endoscopic procedure for weight loss
Primary Outcome Measure Information:
Title
weight loss
Description
total body weight
Time Frame
at 30 days post-intervention
Title
weight loss
Description
total body weight
Time Frame
at 60 days post-intervention
Title
weight loss
Description
total body weight
Time Frame
at 90 days post-intervention
Title
fat mass
Description
% fat mass will be estimated by bioimpedence
Time Frame
at 30 days post-intervention
Title
fat mass
Description
% fat mass will be estimated by bioimpedence
Time Frame
at 60 days post-intervention
Title
fat mass
Description
% fat mass will be estimated by bioimpedence
Time Frame
at 90 days post-intervention
Title
AT-EOS content
Description
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
Title
AT-EOS content
Description
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 Outcome Measure Information:
Title
insulin sensitivity
Description
mixed meal test
Time Frame
at baseline and 90 days post-intervention
Title
inflammation
Description
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
Title
inflammation
Description
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
Title
inflammation
Description
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
Title
adipose tissue inflammation
Description
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
Title
adipose tissue inflammation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
<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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Anna O. De Filippis, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Eosinophils in Human Adipose Tissue
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