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

NCT02378077 | Completed

• 1 other identifier: 14-001288
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Insulin Resistance

Keywords

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Secondary Outcomes (1)

• Relationship between eosinophils content and body mass index (BMI)

  baseline

Other Outcomes (4)

• Change in insulin sensitivity

  Baseline, post fish oil supplementation (approximately 3 months)

• Change in plasma inflammatory cytokines

  Baseline, post fish oil supplementation (approximately 3 months)

• Change in plasma inflammatory adipokines

  Baseline, post fish oil supplementation (approximately 3 months)

Study Arms (2)

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.

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.

Procedure: Fat Aspiration; Dietary Supplement: Fish Oil Supplement

Interventions

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.

Also known as: Fat Aspiration, Tissue Biopsy

Lean or Obese, Non-Diabetic

Fat Aspiration PROCEDURE

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

Also known as: Fat Sample, Adipose Tissue

Fish oil supplementation; Lean or Obese, Non-Diabetic

Fish Oil Supplement DIETARY_SUPPLEMENT

Fish Oil supplementation for three months.

Also known as: Dietary Supplement

Fish oil supplementation

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• 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.

  PMID: 38206766 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elena Anna De Filippis, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant of Endocrinology and Metabolic Disease

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: March 4, 2015
• Study Start: August 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)