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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 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: July 23, 2015
Last verified: July 2015

April 13, 2010
July 23, 2015
April 2010
April 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01104220 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk (201102127)
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk (201102127)

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

plasma and subcutaneous fat

Non-Probability Sample

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.

  • Non-alcoholic Fatty Liver Disease
  • Metabolic Syndrome
  • Metabolically Abnormal Obesity
  • Metabolically Normal Obesity
  • Obesity
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
April 2017
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
Contact: Emily Lake, B.S. 314-747-3758 elake@dom.wustl.edu
United States
 
NCT01104220
201102127
No
Washington University School of Medicine
Washington University School of Medicine
Pfizer
Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
Washington University School of Medicine
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP