Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
Recruiting
- Conditions
- Obesity, MorbidChronic InflammationNASH - Nonalcoholic Steatohepatitis
- Interventions
- Procedure: Bariatric surgery
- Registration Number
- NCT04232566
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Weight loss surgery Bariatric surgery Gastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery.
- Primary Outcome Measures
Name Time Method Liver fibrosis Baseline evaluate the liver fibrosis by elastography before surgical intervention
Adipose tissue inflammation Baseline Evaluate markers of adipose tissue inflammation by mRNA levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States