Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
NCT01104220
Last updated date
ABOUT THIS STUDY
The purpose of this study is to learn more about how the body stores fat in and around organs
(for example in 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.
Study Location
Washington University School of Medicine
Saint Louis, Missouri, 63110, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity, Metabolically Normal Obesity, Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- must be sedentary (regular exercise <1 h/week or <2 times/week for the last 2 months)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity, Metabolically Normal Obesity, ObesityRole of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
NCT01104220
- Saint Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk | ||||
| Official Title ICMJE | Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk | ||||
| Brief Summary | The purpose of this study is to learn more about how the body stores fat in and around organs (for example in 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. | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||
| Condition ICMJE |
| ||||
| Intervention ICMJE | Other: Weight loss
Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight | ||||
| Study Arms ICMJE |
| ||||
| Publications * | Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 144 | ||||
| Original Estimated Enrollment ICMJE | 36 | ||||
| Estimated Study Completion Date ICMJE | December 2020 | ||||
| Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01104220 | ||||
| Other Study ID Numbers ICMJE | 201102127 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Washington University School of Medicine | ||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Washington University School of Medicine | ||||
| Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||