Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk (201102127)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Washington University School of Medicine
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01104220
First received: April 13, 2010
Last updated: February 4, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to learn more about how the body stores fat in and around organs (ex. the liver) and why this affects some people's health more than others. Understanding this may lead to better treatments for diseases such as diabetes and cardiovascular disease.

Condition
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Metabolically Abnormal Obesity
Metabolically Normal Obesity
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk (201102127)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    insulin sensitivity assessed in vivo by using a two-stage euglycemic hyperinsulinemic clamp procedure with stable isotope tracer infusion


Secondary Outcome Measures:
  • TNF-alpha [ Time Frame: baseline ] [ Designated as safety issue: No ]
    TNF-alpha is a marker of inflammation

  • Interleukin-6 (IL-6) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    interleukin-6 is a marker of inflammation


Biospecimen Retention:   Samples With DNA
plasma and subcutaneous fat

Estimated Enrollment: 144
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
lean, metabolically normal
subjects with body mass index 18.5 - 24.9 and normal liver fat (IHTG content <=5%)
obese, metabolically normal
subjects with body mass index >= 30 and normal liver fat (IHTG content <=5%)
obese, metabolically abnormal
subjects with body mass index >=30.0 and increased liver fat (IHTG content >10%)
obese, scheduled for bariatric surgery
subjects with a body mass index 35.0-55.0 kg/m2 undergoing bariatric surgery, who are either metabolically normal or metabolically abnormal

Detailed Description:
The purpose of this study is to determine the specific cellular and organ system metabolic and immunologic alterations that are associated with insulin resistance and inflammation in order to identify putative mechanisms and novel bio-markers involved in the pathogenesis and progression of inflammatory and cardiometabolic diseases.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of subjects of all races and ethnic groups with an equal number of men and women. Participants will be recruited by reviewing our database of research subjects containing thousands of lean and obese research study volunteers and by St. Louis metro area postings.
Criteria

Inclusion Criteria:

  • must be sedentary (regular exercise <1 h/week or <2 times/week for the last 2 months)

Exclusion Criteria:

  • active or previous history of other liver diseases
  • history of alcohol abuse
  • currently consuming ≥20 g alcohol/day
  • diabetes
  • severe hypertriglyceridemia (>300 mg/dL)
  • smoke tobacco
  • medications that might confound the study results
  • pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104220

Contacts
Contact: Emily Lake, B.S. 314-747-3758 elake@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pfizer
Investigators
Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01104220     History of Changes
Other Study ID Numbers: 201102127 
Study First Received: April 13, 2010
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
NAFLD
obesity
metabolic syndrome

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Obesity
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2016