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 type | Observational |
|---|---|
| Ages | 30 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Status | Recruiting |
| Started | February 20, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 30, 2027 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT04232566 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
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States Recruiting
Study contacts
- Principal investigator: Elena Anna O De Filippis — Mayo Clinic
- Study coordinator: Keegan M Stewart
- Email: stewart.keegan@mayo.edu
- Phone: 480-301-4164
Similar studies
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This trial will test whether repeated subcutaneous injections of an experimental drug called B1344 are safe and affect liver fat and related measures in adults with NAFLD or NASH.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.