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Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue

Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02378077
Enrollment
28
Registered
2015-03-04
Start date
2014-08-31
Completion date
2018-10-31
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Obesity, Insulin Resistance

Brief summary

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.

Interventions

PROCEDUREFat biopsy during scheduled abdominal surgery

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.

PROCEDUREFat Aspiration

Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.

DIETARY_SUPPLEMENTFish Oil Supplement

Fish Oil supplementation for three months.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Eosinophil content in adipose tissuebaselineEosinophils number will be measured by flow cytometry in subcutaneous and visceral fat of lean vs obese, non-diabetic volunteers

Secondary

MeasureTime frameDescription
Relationship between eosinophils content and body mass index (BMI)baselineMeasure as a linear regression between BMI (kg/m2) and eosinophils number in the fat

Other

MeasureTime frameDescription
Change in insulin sensitivityBaseline, post fish oil supplementation (approximately 3 months)Measured by euglycemic-hyperinsulinemic clamp taken before and after fish oil supplementation
Change in plasma inflammatory cytokinesBaseline, post fish oil supplementation (approximately 3 months)Measured by Elisa reported in pg/mL before and after fish oil supplementation
Change in plasma inflammatory adipokinesBaseline, post fish oil supplementation (approximately 3 months)Measured by Elisa reported in pg/mL before and after fish oil supplementation
Change in adipose tissue inflammatory markersBaseline, post fish oil supplementation (approximately 3 months)Measured by mRNA levels of pro-inflammatory markers before and after fish oil supplementation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026