Actively Recruiting
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity - AIM 1
Led by Mayo Clinic · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between inflammation in fat tissue, abnormal fat buildup around the liver, and how these factors affect liver appearance, function, and insulin resistance in people with obesity. The study focuses on individuals with morbid obesity who are undergoing gastric bypass surgery to better understand these connections. This observational research is sponsored by Mayo Clinic and includes adults aged 30 to 70 years with a body mass index over 40 kg/m2. Participants will undergo standard care weight loss following gastric bypass surgery. Before the surgery, liver fibrosis will be assessed using elastography to measure liver stiffness. This evaluation helps the researchers understand the degree of liver fibrosis and inflammation in the adipose tissue at the start of the study. During the study, participants will be monitored for liver fibrosis and adipose tissue inflammation at baseline. These assessments involve non-invasive imaging and laboratory tests to track changes over time. The study may include follow-up visits to observe the effects of weight loss surgery on liver and fat tissue health. Participation lasts through the surgery and related evaluations as part of the observational study design.
CONDITIONS
Brief Title
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Normal TSH lab values
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo gastric bypass surgery as part of routine care, with liver fibrosis evaluated by elastography before surgery.
1 surgical visit and immediate post-operative assessments
Duration - Up to 2 years
Participants are monitored for weight loss and health outcomes following surgery.
Periodic follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
K
Keegan M Stewart
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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