Factors Involved in Obesity-related Inflammation and Insulin Resistance

NCT ID: NCT01173705

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Obesity Insulin Resistance Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal weight: abdominal surgery

Lean individuals undergoing elective abdominal surgery

No interventions assigned to this group

Obese: abdominal or bariatic surgery

Obese subjects undergoing elective abdominal or bariatric surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Robyn Tamboli

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robyn Tamboli, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Naji N Abumrad, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #100919

Identifier Type: -

Identifier Source: org_study_id

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