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NCT Number: NCT04232566

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

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.

Recruiting

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Key information

Conditions

Obesity, Morbid Body Weight Chronic Inflammation Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location status: Recruiting

Location contact

Elena De Filippis, MD,PhD

PRINCIPAL_INVESTIGATOR

Stewart Keegan

CONTACT

[email protected]

480-301-4164

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Evaluate liver fibrosis by elastography before gastric bypass surgery.

Other names: Roux en Y gastric bypass, sleeve gastrectomy

Primary outcomes

  1. Liver fibrosis

    Time frame: Baseline

    evaluate the liver fibrosis by elastography before surgical intervention

  2. Adipose tissue inflammation

    Time frame: Baseline

    Evaluate markers of adipose tissue inflammation by mRNA levels

Study contacts

Contact information is provided by the study sponsor or research team.

Keegan M Stewart

CONTACT

[email protected]

480-301-4164

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jan 18, 2020
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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