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

Recruiting

• Conditions: Obesity, Morbid; Chronic Inflammation; NASH - Nonalcoholic Steatohepatitis

• Registration Number: NCT04232566
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2022-02-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States