Factors Involved in Obesity-related Inflammation and Insulin Resistance

Obesity Clinical Trial

Official title:

Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01173705
• Other study ID #: IRB #100919
• Status: Terminated
• Phase: N/A
• First received: July 29, 2010
• Last updated: January 19, 2017
• Start date: June 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate nutrient intake	Using the NHANES Food Questionnaire, we will evaluate nutrient intakes of lean and obese individuals	5 years
Secondary	Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)	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.	5 years