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Completed

NCT Number: NCT02378077

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

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

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fat biopsy during scheduled abdominal surgery

Procedure

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

Fat Aspiration

Procedure

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

Fish Oil Supplement

Dietary Supplement

Fish Oil supplementation for three months.

Other names: Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Relationship between eosinophils content and body mass index (BMI)

    Time frame: baseline

    Measure as a linear regression between BMI (kg/m2) and eosinophils number in the fat

Other outcomes

  1. Change in insulin sensitivity

    Time frame: Baseline, post fish oil supplementation (approximately 3 months)

    Measured by euglycemic-hyperinsulinemic clamp taken before and after fish oil supplementation

  2. Change in plasma inflammatory cytokines

    Time frame: Baseline, post fish oil supplementation (approximately 3 months)

    Measured by Elisa reported in pg/mL before and after fish oil supplementation

  3. Change in plasma inflammatory adipokines

    Time frame: Baseline, post fish oil supplementation (approximately 3 months)

    Measured by Elisa reported in pg/mL before and after fish oil supplementation

  4. Change in adipose tissue inflammatory markers

    Time frame: Baseline, post fish oil supplementation (approximately 3 months)

    Measured by mRNA levels of pro-inflammatory markers before and after fish oil supplementation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2015
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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