Factors Involved in Obesity-related Inflammation and Insulin Resistance

Terminated

• Conditions: Inflammation; Obesity; Insulin Resistance

• Registration Number: NCT01173705
• Lead Sponsor: Vanderbilt University

Brief Summary

In this project, we propose to recruit lean and obese subjects with different ethnic background (African Americans and Caucasians) to study the alterations of lipid and carbohydrate metabolism and determine whether these disturbances are linked to genetic, inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and insulin resistance are frequent features of obesity, we postulate that an unbalanced diet with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation and insulin resistance. We propose to investigate fatty acid metabolism and determine the links between fatty acid composition and oxidative stress in tissues of lean and obese subjects. We propose the following aims:

Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES Food Questionnaire.

Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3 content and inflammatory and oxidative stress markers.

Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Study Start: 2011-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 18-65 years of age
• Undergoing elective abdominal or bariatric surgery

Exclusion Criteria

• Intercurrent infections
• Active cancer diagnosis within 5 years
• Use of medications for diabetes or hyperlipidemia
• Use of glucocorticoids or anti-inflammatory drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine the relationship between omega-3 content and inflammatory and oxidative stress markers	5 years	We will evaluate fatty acid composition in adipose tissues depots, blood monocytes, and skeletal muscle to examine the relationship between omega-e content and inflammatory and oxidative stress markers.

Secondary Outcome Measures

Name	Time	Method
Evaluate nutrient intake	5 years	Using the NHANES Food Questionnaire, we will evaluate nutrient intakes of lean and obese individuals
Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)	5 years	Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States