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

Mayo Clinic

Status: Enrolling

Conditions: Chronic Inflammation; NASH - Nonalcoholic Steatohepatitis; Obesity, Morbid

Treatments: Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04232566

18-004615

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Weight loss surgery

Description:

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

Treatment:

Procedure: Bariatric surgery