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

NCT04232566 | Recruiting

• 1 other identifier: 18-004615
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; NASH - Nonalcoholic Steatohepatitis; Chronic Inflammation

Keywords

obesity; nash; adipose tissue inflammation; insulin resistance

Outcome Measures

Primary Outcomes (2)

• Liver fibrosis

  evaluate the liver fibrosis by elastography before surgical intervention

  Baseline

• Adipose tissue inflammation

  Evaluate markers of adipose tissue inflammation by mRNA levels

  Baseline

Study Arms (1)

Weight loss surgery

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

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

Evaluate liver fibrosis by elastography before gastric bypass surgery.

Also known as: Roux en Y gastric bypass, sleeve gastrectomy

Weight loss surgery

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fourteen subjects with F=0 (no fibrosis) and forty-six patients undergoing gastric bypass Surgery with confirmed Area under the Receiver Operating Characteristic Curve (AUROC) F\>2 (moderate fibrosis), age 30-70yrs, both genders, BMI greater than 40 kg/m2 will be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Non-alcoholic Fatty Liver Disease; Obesity; Insulin Resistance

Interventions

Bariatric Surgery; Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Gastroenterostomy; Anastomosis, Surgical; Digestive System Surgical Procedures

Study Officials

• Elena Anna O De Filippis

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keegan M Stewart

CONTACT

480-301-4164; stewart.keegan@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 18, 2020
• Study Start: February 20, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)