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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378077
• Other study ID #: 14-001288
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: October 2018

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Obesity

Intervention

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

Dietary Supplement:
• Fish Oil Supplement
Fish Oil supplementation for three months.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in insulin sensitivity	Measured by euglycemic-hyperinsulinemic clamp taken before and after fish oil supplementation	Baseline, post fish oil supplementation (approximately 3 months)
Other	Change in plasma inflammatory cytokines	Measured by Elisa reported in pg/mL before and after fish oil supplementation	Baseline, post fish oil supplementation (approximately 3 months)
Other	Change in plasma inflammatory adipokines	Measured by Elisa reported in pg/mL before and after fish oil supplementation	Baseline, post fish oil supplementation (approximately 3 months)
Other	Change in adipose tissue inflammatory markers	Measured by mRNA levels of pro-inflammatory markers before and after fish oil supplementation	Baseline, post fish oil supplementation (approximately 3 months)
Primary	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	Relationship between eosinophils content and body mass index (BMI)	Measure as a linear regression between BMI (kg/m2) and eosinophils number in the fat	baseline

External Links

•   Mayo Clinic Clinical Trials