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

March 23, 2023 updated by: Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic

Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona
        • Contact:
        • Principal Investigator:
          • Elena De Filippis, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Evaluate liver fibrosis by elastography before gastric bypass surgery.
Other Names:
  • Roux en Y gastric bypass, sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver fibrosis
Time Frame: Baseline
evaluate the liver fibrosis by elastography before surgical intervention
Baseline
Adipose tissue inflammation
Time Frame: Baseline
Evaluate markers of adipose tissue inflammation by mRNA levels
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Elena Anna O De Filippis, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-004615

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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