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

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fat biopsy during scheduled abdominal surgery
Fat Aspiration
Fish Oil Supplement
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Insulin Resistance

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lean or Obese, Non-Diabetic

Fish oil supplementation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2014
Last Updated
January 14, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02378077
Brief Title
Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue
Official Title
Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean or Obese, Non-Diabetic
Arm Type
Experimental
Arm Description
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.
Arm Title
Fish oil supplementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fat biopsy during scheduled abdominal surgery
Other Intervention Name(s)
Fat Aspiration, Tissue Biopsy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fat Aspiration
Other Intervention Name(s)
Fat Sample, Adipose Tissue
Intervention Description
Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil Supplement
Other Intervention Name(s)
Dietary Supplement
Intervention Description
Fish Oil supplementation for three months.
Primary Outcome Measure Information:
Title
Eosinophil content in adipose tissue
Description
Eosinophils number will be measured by flow cytometry in subcutaneous and visceral fat of lean vs obese, non-diabetic volunteers
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Relationship between eosinophils content and body mass index (BMI)
Description
Measure as a linear regression between BMI (kg/m2) and eosinophils number in the fat
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
Change in insulin sensitivity
Description
Measured by euglycemic-hyperinsulinemic clamp taken before and after fish oil supplementation
Time Frame
Baseline, post fish oil supplementation (approximately 3 months)
Title
Change in plasma inflammatory cytokines
Description
Measured by Elisa reported in pg/mL before and after fish oil supplementation
Time Frame
Baseline, post fish oil supplementation (approximately 3 months)
Title
Change in plasma inflammatory adipokines
Description
Measured by Elisa reported in pg/mL before and after fish oil supplementation
Time Frame
Baseline, post fish oil supplementation (approximately 3 months)
Title
Change in adipose tissue inflammatory markers
Description
Measured by mRNA levels of pro-inflammatory markers before and after fish oil supplementation
Time Frame
Baseline, post fish oil supplementation (approximately 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Anna De Filippis, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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