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NCT04232566 Clinical Trial

Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity

Obesity, Morbid Clinical Trial

Official title:
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04232566
Other study ID # 18-004615
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2022
Est. completion date July 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - Undergoing gastric bypass surgery - Confirmed AUROC F=0 or F>2 liver fibrosis - Age 30-70 years - BMI greater than 40 kg/m2 - Negative pregnancy test (female only) - Lab Values: Normal TSH Exclusion Criteria: - Autoimmune diseases - Hepatitis B or C positive - Heavy alcohol use - Active smoking history - Active cancer history - History of asthma - History of COPD - Taking Plavix or Coumadin - Blood donation within past 2 months - Glucocorticoid Therapy - Taking antihistamine on regular basis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Bariatric surgery
Evaluate liver fibrosis by elastography before gastric bypass surgery.

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 Liver fibrosis evaluate the liver fibrosis by elastography before surgical intervention Baseline
Primary Adipose tissue inflammation Evaluate markers of adipose tissue inflammation by mRNA levels Baseline
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