Clinical trial NCT04898400: Eosinophils in Human Adipose Tissue
Official title: Role of Eosinophils in Human Adipose Tissue Metabolism
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Insulin Resistance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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).

Primary outcomes:
measure: weight loss
timeFrame: at 30 days post-intervention
measure: weight loss
timeFrame: at 60 days post-intervention
measure: weight loss
timeFrame: at 90 days post-intervention
measure: fat mass
timeFrame: at 30 days post-intervention
measure: fat mass
timeFrame: at 60 days post-intervention
measure: fat mass
timeFrame: at 90 days post-intervention
measure: AT-EOS content
timeFrame: at baseline
measure: AT-EOS content
timeFrame: at 90 days post-intervention
Secondary outcomes:
measure: insulin sensitivity
timeFrame: at baseline and 90 days post-intervention
measure: inflammation
timeFrame: at 30 days post-intervention
measure: inflammation
timeFrame: at 60 days post-intervention
measure: inflammation
timeFrame: at 90 days post-intervention
measure: adipose tissue inflammation
timeFrame: at baseline
measure: adipose tissue inflammation
timeFrame: at 90 days post-intervention
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Elena Anna O. De Filippis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: