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

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NCT01104220

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Study Location
Washington University School of Medicine
Saint Louis, Missouri, 63110, United States
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Contact
314-362-8250
[email protected]
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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
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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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
  1. 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
  • Non-alcoholic Fatty Liver Disease
  • Metabolic Syndrome
  • Metabolically Abnormal Obesity
  • Metabolically Normal Obesity
  • Obesity
Intervention  ICMJE Other: Weight loss
Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight
Study Arms  ICMJE
  • No Intervention: Lean, metabolically normal
    Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.
  • No Intervention: Obese, metabolically normal
    Subjects with body mass index ?30.0 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.
  • No Intervention: Obese, metabolically abnormal
    Subjects with body mass index ?30.0 kg/m² and impaired fasting or oral glucose tolerance and increased liver fat.
  • Experimental: Obese, scheduled for bariatric surgery
    Subjects with a body mass index ?35.0 kg/m² undergoing bariatric surgery
    Intervention: Other: Weight loss
  • No Intervention: Obese, scheduled for gallbladder surgery
    Subjects with a body mass index ?35.0 kg/m² undergoing gallbladder surgery
  • No Intervention: Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery
    Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.
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
 (submitted: July 23, 2015)		144
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2010)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Beth Henk314-362-8250[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator:Samuel Klein, M.D.Washington University School of Medicine
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