ObesityNCT02378077
Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue
A study testing Fat biopsy during scheduled abdominal surgery, Fat Aspiration and Fish Oil Supplement in people with Obesity and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue . Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Fat biopsy during scheduled abdominal surgery, Fat Aspiration and Fish Oil Supplement
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2018
- 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
Lean, healthy person with a body mass index (BMI) of 25 or less, or you are obese, BMI between 30 and 50, and non-diabetic.
Lean healthy controls will not be on any medication and will be undergoing elective abdominal surgery excluding those involving acute inflammation (i.e. acute cholecystitis, bowel perforation, or diverticulitis).
Obese, non-diabetic subjects will have a BMI between 30 and 50 and be taking no medications affecting glucose metabolism or lipid metabolism. These subjects will be identified from a pool of patients undergoing an elective abdominal surgical procedure such as inguinal hernia repair, laparoscopic Nissen fundoplication, planned cholecystectomy, but also bariatric surgery.
Volunteers will not be taking corticosteroid therapy or have a history of asthma, COPD or atopic syndrome. All subjects will undergo a medical history intake and a physical examination followed by an OGTT to confirm normal glucose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2
This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .
Read the detailed description
This study is being done to determine whether eosinophils (a type of white blood cell) play an important role in human fat metabolism and inflammation.
This study is being done to determine if fish oil supplement could play a role in reducing inflammation and improving insulin sensitivity in your fat tissue.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Fat biopsy during scheduled abdominal surgery, Fat Aspiration, Fish Oil Supplement
- Keywords
- Obesity, Insulin Resistance
- 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.
Fat biopsy during scheduled abdominal surgeryProcedure or surgery
Also called Fat Aspiration, Tissue Biopsy
Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Fat tissue biopsy during a scheduled abdominal surgery.
Fat AspirationProcedure or surgery
Also called Fat Sample, Adipose Tissue
Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.
Fish Oil SupplementDietary supplement
Also called Dietary Supplement
Fish Oil supplementation for three months.
| Study group | Role | What they receive |
|---|---|---|
| Lean or Obese, Non-Diabetic | Experimental | To determine whether eosinophil content of adipose tissue is related to insulin sensitivity. We will use euglycemic clamps, fat biopsy (obtained during a scheduled abdominal surgery) and fat aspiration for analysis of subcutaneous (Sc) and omental (OM) adipose tissue from obese, insulin resistant and lean, insulin sensitive volunteers to test the hypothesis that, as in mice, eosinophil content in human subcutaneous and omental white adipose tissue, inversely correlates with body weight, with skeletal muscle and hepatic insulin sensitivity. Receives: Procedure: Fat biopsy during scheduled abdominal surgery; Procedure: Fat Aspiration |
| Fish oil supplementation | Experimental | Determine whether, in adipose tissue, levels of, anti-inflammatory molecules correlate with insulin sensitivity and whether these levels are altered by a treatment designed to promote resolution of inflammation. Volunteers will take a fish oil supplement for three months. Receives: Procedure: Fat Aspiration; Dietary Supplement: Fish Oil Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophil content in adipose tissue
Eosinophils number will be measured by flow cytometry in subcutaneous and visceral fat of lean vs obese, non-diabetic volunteers
Measured: baseline
Secondary outcomes (1)
Relationship between eosinophils content and body mass index (BMI)
Measure as a linear regression between BMI (kg/m2) and eosinophils 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 posted4 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2018
- Study completionOct 2018
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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 De Filippis, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378077
- Sponsor's protocol ID
- 14-001288
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2
- ClinicalTrials.gov ID
- NCT02378077
- Acronym / sponsor ID
- 14-001288
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 and insulin resistance in your Adipose (fat) Tissue .
Detailed description
This study is being done to determine whether eosinophils (a type of white blood cell) play an important role in human fat metabolism and inflammation.
This study is being done to determine if fish oil supplement could play a role in reducing inflammation and improving insulin sensitivity in your fat tissue.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean or Obese, Non-Diabetic | Experimental | Procedure: Fat biopsy during scheduled abdominal surgery, Procedure: Fat AspirationTo determine whether eosinophil content of adipose tissue is related to insulin sensitivity. We will use euglycemic clamps, fat biopsy (obtained during a scheduled abdominal surgery) and fat aspiration for analysis of subcutaneous (Sc) and omental (OM) adipose tissue from obese, insulin resistant and lean, insulin sensitive volunteers to test the hypothesis that, as in mice, eosinophil content in human subcutaneous and omental white adipose tissue, inversely correlates with body weight, with skeletal muscle and hepatic insulin sensitivity. |
| Fish oil supplementation | Experimental | Procedure: Fat Aspiration, Dietary Supplement: Fish Oil SupplementDetermine whether, in adipose tissue, levels of, anti-inflammatory molecules correlate with insulin sensitivity and whether these levels are altered by a treatment designed to promote resolution of inflammation. Volunteers will take a fish oil supplement for three months. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 biopsy during scheduled abdominal surgeryAlso: Fat Aspiration, Tissue BiopsyPhysical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Fat tissue biopsy during a scheduled abdominal surgery. | Procedure or surgery | Lean or Obese, Non-Diabetic |
| Fat AspirationAlso: Fat Sample, Adipose TissuePhysical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy. | Procedure or surgery | Fish oil supplementation, Lean or Obese, Non-Diabetic |
| Fish Oil SupplementAlso: Dietary SupplementFish Oil supplementation for three months. | Dietary supplement | Fish oil supplementation |
Primary outcome
Eosinophil content in adipose tissue
Time frame: baseline
Eosinophils number will be measured by flow cytometry in subcutaneous and visceral fat of lean vs obese, non-diabetic volunteers
1 secondary outcome
Relationship between eosinophils 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 18 Jan 2020.
- 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.
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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 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 Fat biopsy during scheduled abdominal surgery, Fat Aspiration and Fish Oil Supplement 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?
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 18 Jan 2020. 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?
Eosinophil content 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 NCT02378077, 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 18 Jan 2020.