Overview

This trial is active, not recruiting.

Conditions obesity, insulin resistance, inflammation
Sponsor Vanderbilt University
Start date June 2011
End date December 2016
Trial size 120 participants
Trial identifier NCT01173705, IRB #100919

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
Lean individuals undergoing elective abdominal surgery
Obese subjects undergoing elective abdominal or bariatric surgery

Primary Outcomes

Measure
Examine the relationship between omega-3 content and inflammatory and oxidative stress markers
time frame: 5 years

Secondary Outcomes

Measure
Evaluate nutrient intake
time frame: 5 years
Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance
Principal investigator Robyn Tamboli, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.