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Trial record 13 of 668 for:    Recruiting, Not yet recruiting, Available Studies | "Insulins"

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

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ClinicalTrials.gov Identifier: NCT02378077
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic

Brief Summary:
This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Procedure: Fat biopsy during scheduled abdominal surgery Procedure: Fat Aspiration Dietary Supplement: Fish Oil Supplement Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2
Study Start Date : August 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lean or Obese, Non-Diabetic
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.
Procedure: Fat 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.
Other Names:
  • Fat Aspiration
  • Tissue Biopsy

Procedure: Fat Aspiration
Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.
Other Names:
  • Fat Sample
  • Adipose Tissue

Experimental: Fish oil supplementation
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.
Procedure: Fat Aspiration
Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.
Other Names:
  • Fat Sample
  • Adipose Tissue

Dietary Supplement: Fish Oil Supplement
Fish Oil supplementation for three months.
Other Name: Dietary Supplement




Primary Outcome Measures :
  1. Eosinophil content [ Time Frame: Up to 2 Years ]
    Evaluation of eosinophils content in different depots of fat tissue (subcutaneous and visceral) of lean vs obese, non-diabetic volunteers. Evaluation will be conducted on subfraction of stroma vascular component of whole fat tissue subjected to Flow cytometry. Using cell surface markers we will isolate different cell population which will then be reported as a fraction of total cells as well as normalization per gr of whole tissue. Outcome will be assessed on whole sample size at study completion


Secondary Outcome Measures :
  1. Relationship between eosinophils content and insulin sensitivity [ Time Frame: Up to 2 Years ]
    Will explore whether differences in eosinophils content in different fat depots will correlate with insulin sensitivity of all subjects enrolled in the study. Results will be expressed as a linear regression between insulin sensitivity indices expressed as mg/ml x Kg of total body weight x min and eosinophils content expressed as fraction of total cell number. Outcome will be assessed on whole sample size at study completion


Other Outcome Measures:
  1. Effect of fish oil supplementation on eosinophils content and anti-inflammatory molecules [ Time Frame: Up to 2 Years ]
    We will test whether 3 months of fish oil treatment positively affects insulin sensitivity by changing the number of eosinophils or the level of anti-inflammatory molecules. Determination by Elisa of cytokines before and after treatment will be compared (Arbitrary units) and flow cytometry w/ same approach described in outcome one will be applied before and after fish oil



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378077


Contacts
Contact: Charlene Robinson 480-301-4626 ARZClinicalStudies@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Charlene Robinson    480-301-4626    ARZClinicalStudies@mayo.edu   
Principal Investigator: Elena De Filippis, MD PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elena Anna De Filippis, MD, PhD Mayo Clinic

Responsible Party: Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Senior Consultant of Endocrinology and Metabolic Disease, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02378077     History of Changes
Other Study ID Numbers: 14-001288
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic:
Obesity
Insulin Resistance

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs