Investigating the Link Between Type 2 Immunity and NAFLD... | NCT04232566

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

NCT04232566

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Obesity, Morbid
NASH - Nonalcoholic Steatohepatitis
Chronic Inflammation

Interventions

Bariatric surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 15, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bariatric surgery	Procedure	Evaluate liver fibrosis by elastography before gastric bypass surgery.	Weight loss surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keegan M Stewart	Contact	480-301-4164		stewart.keegan@mayo.edu

Overall Officials

Name	Affiliation	Role
Elena Anna O De Filippis	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona	Recruiting	Scottsdale	Arizona	85259	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D065626	Non-alcoholic Fatty Liver Disease
D009765	Obesity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery
D015390	Gastric Bypass

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided