Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT01104220
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.
This study is active but is not currently recruiting participants.
18 year–90 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight
Time frame: Baseline
Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion
Time frame: Baseline
TNF-alpha is a marker of inflammation
Time frame: Baseline
Interleukin-6 is a marker of inflammation
Time frame: Baseline
Liver immune cell content
Time frame: Baseline only in participants scheduled for bariatric surgery
Subcutaneous, omental and transverse mesocolic adipose tissue
Time frame: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Subcutaneous and omental adipose tissue
Time frame: Baseline (All groups)
Immune cell content in abdominal and femoral subcutaneous adipose tissue
Time frame: Baseline only in participants scheduled for bariatric surgery
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood, subcutaneous, omental and transverse mesocolic adipose tissue and liver.
Time frame: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood, subcutaneous and omental adipose tissue
Time frame: Baseline only in all participants
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and abdominal and femoral subcutaneous adipose tissue.
Time frame: Before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and adipose tissue
Time frame: Baseline only in people scheduled for gallbladder or bariatric surgery
Synthesis rates assessed by stable isotope techniques in the fasted vs the fed states
Washington University School of Medicine
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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