Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
NCT01104220
ABOUT THIS STUDY
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Lean, metabolically healthy group - Body mass index (BMI) 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.
Obese, metabolically healthy group - BMI ≥30 kg/m2, HHbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.
Obese, metabolically healthy group - BMI ≥30 kg/m2, IHTG content ≥5.6% and HbA1C ≥5.7% or fasting plasma glucose concentration ≥100 mg/dl or 2-h OGTT plasma glucose concentration ≥140 mg/dl.
Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery - BMI 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and IHTG content ≤5%.
Obese, scheduled for bariatric and gallbladder surgery - BMI ≥35.0kg/m2
Obese, scheduled for bariatric and gallbladder surgery (subgroup) - BMI ≥35.0kg/m2 with either the I148I or the M148M variant for the PNPLA3 SNP rs738409.
- active or previous history of liver diseases other than NAFLD
- history of alcohol abuse
- currently consuming ≥20 g alcohol/day
- severe hypertriglyceridemia (>300 mg/dL)
- smoke tobacco
- cancer diagnosis within the previous 5 years
- medications that might confound the study results
- pregnancy or lactation
- exercise >2 h/week
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Descriptive Information | |||||
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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 |
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Intervention ICMJE | Other: Weight loss
Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight | ||||
Study Arms ICMJE |
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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 | Recruiting | ||||
Estimated Enrollment ICMJE | 144 | ||||
Original Estimated Enrollment ICMJE | 36 | ||||
Estimated Study Completion Date ICMJE | December 2023 | ||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Lean, metabolically healthy group - Body mass index (BMI) 18.5-24.9 kg/m2, HbA1C ?5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ?5%. Obese, metabolically healthy group - BMI ?30 kg/m2, HHbA1C ?5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ?5%. Obese, metabolically healthy group - BMI ?30 kg/m2, IHTG content ?5.6% and HbA1C ?5.7% or fasting plasma glucose concentration ?100 mg/dl or 2-h OGTT plasma glucose concentration ?140 mg/dl. Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery - BMI 18.5-24.9 kg/m2, HbA1C ?5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and IHTG content ?5%. Obese, scheduled for bariatric and gallbladder surgery - BMI ?35.0kg/m2 Obese, scheduled for bariatric and gallbladder surgery (subgroup) - BMI ?35.0kg/m2 with either the I148I or the M148M variant for the PNPLA3 SNP rs738409. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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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 |
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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 |
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PRS Account | Washington University School of Medicine | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |