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Factors Involved in Obesity-related Inflammation and Insulin Resistance

Sponsor
Vanderbilt University (Other)
Overall Status
Terminated
CT.gov ID
NCT01173705
Collaborator
(none)
62
Enrollment
1
Location
31
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance
    Study Start Date :
    Jun 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    Jan 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Normal weight: abdominal surgery

    Lean individuals undergoing elective abdominal surgery
    Obese: abdominal or bariatic surgery

    Obese subjects undergoing elective abdominal or bariatric surgery

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Evaluate nutrient intake [5 years]

      Using the NHANES Food Questionnaire, we will evaluate nutrient intakes of lean and obese individuals

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University

    Investigators

    • Principal Investigator: Robyn Tamboli, PhD, Vanderbilt University Medical Center
    • Study Chair: Naji N Abumrad, MD, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robyn Tamboli, Research Assistant Professor, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT01173705
    Other Study ID Numbers:
    • IRB #100919
    First Posted:
    Aug 2, 2010
    Last Update Posted:
    Jan 20, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Robyn Tamboli, Research Assistant Professor, Vanderbilt University
    Obesity
    Insulin Resistance
    Inflammation
    Additional relevant MeSH terms:
    Obesity
    Insulin Resistance
    Inflammation

    Study Results

    No Results Posted as of Jan 20, 2017