Insulin Resistance, Obesity
Conditions
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.
Interventions
PROCEDUREendoscopy sleeve gastroplasty
endoscopic procedure for weight loss
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | at 30 days post-intervention | total body weight |
| fat mass | at 30 days post-intervention | % fat mass will be estimated by bioimpedence |
| AT-EOS content | at baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| insulin sensitivity | at baseline and 90 days post-intervention | mixed meal test |
| inflammation | at 30 days post-intervention | 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 | at baseline | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElena Anna O. De Filippis, MD, PhD
Mayo Clinic
Outcome results
None listed