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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04234295
Other study ID # 19-003803
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 29, 2020
Est. completion date January 17, 2022

Study information

Verified date January 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 17, 2022
Est. primary completion date January 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Adults ages 30-50 years - Non-smokers - Lean subjects with a BMI of 25 or less, gender specific normal body fat, - Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism - subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery Exclusion Criteria: - Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome - taking any biologic treatment for any autoimmune disorder - Taking any leukotriene receptor antagonist acting medications (ex. Montelukast) - smoking

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Fat Tissue Biopsy
If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.

Locations

Country Name City State
United States Mayo Clinic 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
Other Quantification of the difference in gene methylation in eosinophils from lean and obese subjects Gene methylation of eosinophils will be quantified in samples derived from lean and obese fat biopsy baseline
Primary Number of eosinophils in adipose tissue eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue baseline
Secondary Correlation between eosinophil content and body mass index (BMI) Measured as a linear regression between BMI (defined as the weight in Kg/height in square m; kg/m2) and eosinophil number in the fat baseline
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