ObesityNCT04898400
Eosinophils in Human Adipose Tissue
A study testing endoscopy sleeve gastroplasty in people with Obesity and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- endoscopy sleeve gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity (BMI>30 kg/m2).
- Evidence of insulin resistance as defined by hemoglobin A1c > 5.7%.
- Mayo Clinic patients evaluated by Dr. Rahul Pannala.
- Pursue an endoscopic gastroplasty at Mayo Clinic Arizona in the Gastroenterology department.
- Equal distribution of gender.
- 18 yo older of age.
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- BMI>30 kg/m2.
- Nonsmoker.
- Taking no medication affecting glucose or lipid metabolism.
- No more than 5% change in body weight in the previous 6 months.
- Mostly sedentary (engaging in strenuous exercise (> 70% max HR) less than 3 times a week).
- Not be receiving corticosteroid therapy.
- Have no history of asthma, COPD or atopic syndrome, or autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).
Who cannot join
- <17 years of age.
- BMI <30 kg/m2.
- Smoker.
- Taking medication affecting glucose or lipid metabolism.
- Greater than 5% change in body weight within the previous six months.
- Engage in strenuous exercise (>70% max HR) less than 3 times a week.
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- Receiving corticosteroid therapy.
- Have a history of asthma.
- History of COPD or atopic syndrome.
- History of autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Eosinophils in Human Adipose Tissue Metabolism
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- endoscopy sleeve gastroplasty
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopy sleeve gastroplastyProcedure or surgery
endoscopic procedure for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Obesity | Experimental | Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure Receives: Procedure: endoscopy sleeve gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
total body weight
Measured: at 30 days post-intervention
weight loss
total body weight
Measured: at 60 days post-intervention
weight loss
total body weight
Measured: at 90 days post-intervention
fat mass
% fat mass will be estimated by bioimpedence
Measured: at 30 days post-intervention
fat mass
% fat mass will be estimated by bioimpedence
Measured: at 60 days post-intervention
fat mass
% fat mass will be estimated by bioimpedence
Measured: at 90 days post-intervention
AT-EOS content
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
Measured: at baseline
AT-EOS content
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
Measured: at 90 days post-intervention
Secondary outcomes (6)
insulin sensitivity
mixed meal test
Measured: at baseline and 90 days post-intervention
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
Measured: at 30 days post-intervention
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
Measured: at 60 days post-intervention
inflammation
Plasma will be isolated during fasting condition. MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin will be assessed via Multiplex ELISA
Measured: at 90 days post-intervention
adipose tissue inflammation
subcutaneous fat biopsy will be processed to obtain mRNA. mRNA levels for MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin gene will be assessed via qPCR
Measured: at baseline
adipose tissue inflammation
subcutaneous fat biopsy will be processed to obtain mRNA. mRNA levels for MCP-1, TNFa, IL-4, IL-13, Leptin, adiponectin gene will be assessed via qPCR
Measured: at 90 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
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, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898400
- Sponsor's protocol ID
- 21-000959
- Status last verified
- Jan 2026
- First submitted
- 16 May 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Role of Eosinophils in Human Adipose Tissue Metabolism
- ClinicalTrials.gov ID
- NCT04898400
- Acronym / sponsor ID
- 21-000959
- Conditions
- Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 24 May 2021 (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.
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Obesity | Experimental | Procedure: endoscopy sleeve gastroplastySubjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Obesity (BMI>30 kg/m2).
- Evidence of insulin resistance as defined by hemoglobin A1c > 5.7%.
- Mayo Clinic patients evaluated by Dr. Rahul Pannala.
- Pursue an endoscopic gastroplasty at Mayo Clinic Arizona in the Gastroenterology department.
- Equal distribution of gender.
Key exclusion criteria (10 listed)
- <17 years of age.
- BMI <30 kg/m2.
- Smoker.
- Taking medication affecting glucose or lipid metabolism.
- Greater than 5% change in body weight within the previous six months.
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 |
|---|---|---|
| endoscopy sleeve gastroplastyendoscopic procedure for weight loss | Procedure or surgery | Subjects with Obesity |
Primary outcome
weight loss
Time frame: at 30 days post-intervention
total body weight
weight loss
Time frame: at 60 days post-intervention
total body weight
weight loss
Time frame: at 90 days post-intervention
total body weight
fat mass
Time frame: at 30 days post-intervention
% fat mass will be estimated by bioimpedence
fat mass
Time frame: at 60 days post-intervention
% fat mass will be estimated by bioimpedence
fat mass
Time frame: at 90 days post-intervention
% fat mass will be estimated by bioimpedence
AT-EOS content
Time frame: at baseline
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
AT-EOS content
Time frame: at 90 days post-intervention
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
6 secondary outcomes
insulin sensitivity
Time frame: at baseline and 90 days post-intervention
inflammation
Time frame: at 30 days post-intervention
inflammation
Time frame: at 60 days post-intervention
inflammation
Time frame: at 90 days post-intervention
adipose tissue inflammation
Time frame: at baseline
adipose tissue inflammation
Time frame: at 90 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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. This study is not recruiting at the moment.
Elena Anna O. De Filippis, MD, PhD 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?
A study testing endoscopy sleeve gastroplasty in people with Obesity and Insulin Resistance, 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 13 inclusion and 10 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: at 30 days post-intervention). The study lists 8 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.