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Recruiting NCT04232566

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

— Observational Obesity, Morbid NASH - Nonalcoholic Steatohepatitis Chronic Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric surgery.
Who it may be relevant to
Registry conditions: Obesity, Morbid, NASH - Nonalcoholic Steatohepatitis, Chronic Inflammation. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Bariatric surgery
    Evaluate liver fibrosis by elastography before gastric bypass surgery.

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Arizona — Scottsdale

Identifiers

NCT: NCT04232566 · 18-004615

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗