Clinical trial Recruiting at 1 site Observational Ages 30 to 70

Understanding the connection between obesity and liver inflammation

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

Run by Mayo Clinic · NCT04232566 · Data updated 2026-11-12

This study looks at how extra fat around the liver and inflammation in body fat affect liver health and insulin resistance in people with obesity, especially those having gastric bypass surgery.

Quick facts

Study typeObservational
Ages30 Years to 70 Years
SexAll
Enrollment60 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Scottsdale, Arizona)
StatusRecruiting
StartedFebruary 20, 2022
Main results expectedDecember 31, 2025
Study endsDecember 30, 2027
Registry record updatedJanuary 28, 2026
Trial IDNCT04232566 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 30-70 with a BMI greater than 40 kg/m2 who are undergoing gastric bypass surgery.

Probably not a fit

Patients with autoimmune diseases, active cancer, or those who have a history of heavy alcohol use may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the relationship between inflammation in adipose tissue and the abnormal fat deposition around the liver in individuals with obesity. It focuses on how these factors influence liver function and insulin resistance, particularly in patients undergoing gastric bypass surgery. By analyzing data from participants with confirmed liver fibrosis, the study seeks to provide insights into the mechanisms linking obesity and liver health.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of liver-related complications in obese patients.

How similar studies have gone: Other studies have explored the relationship between obesity and liver health, but this specific approach focusing on adipose tissue inflammation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Mayo Clinic in Arizona
    Scottsdale, Arizona, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.