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Factors Involved in Obesity-related Inflammation and Insulin Resistance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01173705
First received: July 29, 2010
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Obesity
Insulin Resistance
Inflammation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Examine the relationship between omega-3 content and inflammatory and oxidative stress markers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Evaluate nutrient intake [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Whole blood, omentum biopsy, subcutaneous fat biopsy, muscle biopsy (abdominal wall)


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal weight: abdominal surgery
Lean individuals undergoing elective abdominal surgery
Obese: abdominal or bariatic surgery
Obese subjects undergoing elective abdominal or bariatric surgery

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Normal weight and obese subjects who are undergoing elective bariatric or abdominal surgery

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173705

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Tahar Tamboli, PhD Vanderbilt University
Study Chair: Naji N Abumrad, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Robyn Tamboli, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01173705     History of Changes
Other Study ID Numbers: IRB #100919
Study First Received: July 29, 2010
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Obesity
Insulin Resistance
Inflammation

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Obesity
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013