ObeseNCT04234295
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
A study testing Fat Tissue Biopsy in people with Obese and Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Fat Tissue Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 17 Jan 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ages 30-50 years
- Non-smokers
- Lean subjects with a BMI of 25 or less, gender specific normal body fat,
- Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism
- subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery
Who cannot join
- Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome
- taking any biologic treatment for any autoimmune disorder
- Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.
- Being tested
- Fat Tissue Biopsy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat Tissue BiopsyProcedure or surgery
If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Lean, Healthy Controls | Active comparator | Subjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected Receives: Procedure: Fat Tissue Biopsy |
| Obese, Non-Diabetic | Experimental | Subject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected Receives: Procedure: Fat Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eosinophils in adipose tissue
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
Measured: baseline
Secondary outcomes (1)
Correlation between eosinophil content and body mass index (BMI)
Measured as a linear regression between BMI (defined as the weight in Kg/height in square m; kg/m2) and eosinophil number in the fat
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start29 Jan 2020
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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 De Filippis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234295
- Sponsor's protocol ID
- 19-003803
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez JD, Li T, Ghannam H, Rau CM, Masuda MY, Madura JA 2nd, Jacobsen EA, De Filippis E. Linking adipose tissue eosinophils, IL-4, and leptin in human obesity and insulin resistance. JCI Insight. 2024 Feb 8;9(3):e170772. doi: 10.1172/jci.insight.170772.
PubMed 38206766
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
- ClinicalTrials.gov ID
- NCT04234295
- Acronym / sponsor ID
- 19-003803
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 21 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.
Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean, Healthy Controls | Active comparator | Procedure: Fat Tissue BiopsySubjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected |
| Obese, Non-Diabetic | Experimental | Procedure: Fat Tissue BiopsySubject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults ages 30-50 years
- Non-smokers
- Lean subjects with a BMI of 25 or less, gender specific normal body fat,
- Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism
- subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery
Key exclusion criteria (4 listed)
- Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome
- taking any biologic treatment for any autoimmune disorder
- Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)
- smoking
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 |
|---|---|---|
| Fat Tissue BiopsyIf subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected. | Procedure or surgery | Lean, Healthy Controls, Obese, Non-Diabetic |
Primary outcome
Number of eosinophils in adipose tissue
Time frame: baseline
eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue
1 secondary outcome
Correlation between eosinophil content and body mass index (BMI)
Time frame: baseline
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 19 Jan 2022.
- Derived from this study: PubMed 38206766Hernandez JD, Li T, Ghannam H, Rau CM, Masuda MY, Madura JA 2nd, Jacobsen EA, De Filippis E. Linking adipose tissue eosinophils, IL-4, and leptin in human obesity and insulin resistance. JCI Insight. 2024 Feb 8;9(3):e170772. doi: 10.1172/jci.insight.170772.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Elena De Filippis, MD 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 Fat Tissue Biopsy in people with Obese and Healthy, 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 5 inclusion and 4 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 19 Jan 2022. 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?
Number of eosinophils in adipose tissue (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234295, which also lists 1 linked publication.
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 19 Jan 2022.