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Search / Trial NCT04232566

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

Launched by MAYO CLINIC · Jan 15, 2020

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Obesity Nash Adipose Tissue Inflammation Insulin Resistance

ClinConnect Summary

This clinical trial is exploring how inflammation in body fat and fat buildup around the liver may affect liver health and insulin resistance in people with obesity. Specifically, the researchers want to understand the connection between type 2 immunity (a part of our immune system) and nonalcoholic fatty liver disease (NAFLD) in individuals who are undergoing gastric bypass surgery.

To be eligible for this study, participants should be between 30 and 70 years old, have a body mass index (BMI) over 40, and have confirmed liver fibrosis (a condition where the liver becomes scarred) of a certain level. Importantly, participants should not have certain conditions like autoimmune diseases, active cancer, or heavy alcohol use. If you choose to take part, you can expect to undergo assessments related to your liver health and inflammation. This research could help improve our understanding of obesity-related liver problems and potentially lead to better treatments in the future.

Gender

ALL

Eligibility 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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Scottsdale, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Elena Anna O De Filippis

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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