Factors Involved in Obesity-related Inflammation and Insulin Resistance

NCT01173705 | Terminated

• 1 other identifier: IRB #100919
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Insulin Resistance; Inflammation

Keywords

Obesity; Insulin Resistance; Inflammation

Outcome Measures

Primary Outcomes (1)

• Examine the relationship between omega-3 content and inflammatory and oxidative stress markers

  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.

  5 years

Secondary Outcomes (2)

• Evaluate nutrient intake

  5 years

• Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)

  5 years

Study Arms (2)

Normal weight: abdominal surgery

Lean individuals undergoing elective abdominal surgery

Obese: abdominal or bariatic surgery

Obese subjects undergoing elective abdominal or bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years of age
• Undergoing elective abdominal or bariatric surgery

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• Robyn Tamboli, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Naji N Abumrad, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: June 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)