Understanding the connection between obesity and liver inflammation
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1
Mayo Clinic · NCT04232566
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT04232566 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored the relationship between obesity and liver health, but this specific approach focusing on adipose tissue inflammation is relatively novel.
Eligibility criteria
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 this trial is running
Scottsdale, Arizona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Morbid, NASH - Nonalcoholic Steatohepatitis, Chronic Inflammation, obesity, nash, adipose tissue inflammation, insulin resistance