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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04898400
Other study ID # 21-000959
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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