Obesity, MorbidNCT04232566
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
An observational study of Obesity, Morbid and NASH - Nonalcoholic Steatohepatitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, NASH - Nonalcoholic Steatohepatitis, Chronic Inflammation
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2022to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Autoimmune diseases
- Hepatitis B or C positive
- Heavy alcohol use
- Active smoking history
- Active cancer history
- History of asthma
Show all 11Show fewer
- History of COPD
- Taking Plavix or Coumadin
- Blood donation within past 2 months
- Glucocorticoid Therapy
- Taking antihistamine on regular basis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Stewart Keegan, 480-301-4164, stewart.keegan@mayo.edu
Elena De Filippis, MD,PhD
About this study
Official title: 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.
- Being tested
- Bariatric surgery
- Keywords
- obesity, nash, adipose tissue inflammation, insulin resistance
- Medical subject headings
- Obesity, Morbid, Non-alcoholic Fatty Liver Disease, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called Roux en Y gastric bypass, sleeve gastrectomy
Evaluate liver fibrosis by elastography before gastric bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis
evaluate the liver fibrosis by elastography before surgical intervention
Measured: Baseline
Adipose tissue inflammation
Evaluate markers of adipose tissue inflammation by mRNA levels
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Feb 2022
- Primary completion31 Dec 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic
- Investigators
- Elena Anna O De Filippis, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232566
- Sponsor's protocol ID
- 18-004615
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2019
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1
- ClinicalTrials.gov ID
- NCT04232566
- Acronym / sponsor ID
- 18-004615
- Keywords
- obesity, nash, adipose tissue inflammation, insulin resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss surgery | – | Procedure: Bariatric surgeryGastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- Autoimmune diseases
- Hepatitis B or C positive
- Heavy alcohol use
- Active smoking history
- Active cancer history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryAlso: Roux en Y gastric bypass, sleeve gastrectomyEvaluate liver fibrosis by elastography before gastric bypass surgery. | Procedure or surgery | Weight loss surgery |
Primary outcome
Liver fibrosis
Time frame: Baseline
evaluate the liver fibrosis by elastography before surgical intervention
Adipose tissue inflammation
Time frame: Baseline
Evaluate markers of adipose tissue inflammation by mRNA levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Anna O De Filippis principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and NASH - Nonalcoholic Steatohepatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keegan M Stewart (480-301-4164, stewart.keegan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fibrosis (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.