Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04232566

Conditions

Obesity, Morbid

NASH - Nonalcoholic Steatohepatitis

Chronic Inflammation

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Bariatric surgery

Study Details

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.

Conditions

Obesity, Morbid

NASH - Nonalcoholic Steatohepatitis

Chronic Inflammation

Study ID

NCT04232566

Start date

Feb 20, 2022

Status verified date

Jan, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Weight loss surgery

Gastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery.

Interventions

Bariatric surgery

Evaluate liver fibrosis by elastography before gastric bypass surgery.

Primary outcome measure

  • Liver fibrosis [ Time Frame: Baseline ]
  • Adipose tissue inflammation [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Keegan M Stewart

480-301-4164stewart.keegan@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Stewart Keegan

480-301-4164stewart.keegan@mayo.edu

Principal Investigator:

Elena De Filippis, MD,PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • obesity
  • nash
  • adipose tissue inflammation
  • insulin resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-28.