Eosinophils in Human Adipose Tissue

Obesity Clinical Trial

Official title:

Role of Eosinophils in Human Adipose Tissue Metabolism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04898400
• Other study ID #: 21-000959
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Procedure:
• endoscopy sleeve gastroplasty
endoscopic procedure for weight loss

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	total body weight	at 30 days post-intervention
Primary	weight loss	total body weight	at 60 days post-intervention
Primary	weight loss	total body weight	at 90 days post-intervention
Primary	fat mass	% fat mass will be estimated by bioimpedence	at 30 days post-intervention
Primary	fat mass	% fat mass will be estimated by bioimpedence	at 60 days post-intervention
Primary	fat mass	% fat mass will be estimated by bioimpedence	at 90 days post-intervention
Primary	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
Primary	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	insulin sensitivity	mixed meal test	at baseline and 90 days post-intervention
Secondary	inflammation	Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA	at 30 days post-intervention
Secondary	inflammation	Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA	at 60 days post-intervention
Secondary	inflammation	Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA	at 90 days post-intervention
Secondary	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	at baseline
Secondary	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	at 90 days post-intervention