We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104220
First Posted: April 15, 2010
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
  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 ]
    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 ]
    TNF-alpha is a marker of inflammation

  • Interleukin-6 (IL-6) [ Time Frame: Baseline ]
    Interleukin-6 is a marker of inflammation


Biospecimen Retention:   Samples With DNA
Plasma and subcutaneous fat

Estimated Enrollment: 144
Actual Study Start Date: April 2010
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lean, metabolically normal
Subjects with body mass index 18.5 - 24.9 kg/m² and normal liver fat (IHTG content ≤5%)
Obese, metabolically normal
Subjects with body mass index ≥30.0 kg/m² and normal liver fat (IHTG content ≤5%)
Obese, metabolically abnormal
Subjects with body mass index ≥30.0 kg/m² 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104220


Locations
United States, Missouri
Washington University School of Medicine
Saint 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
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: August 30, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
NAFLD
Obesity
Metabolic syndrome

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