Clinical trial
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT01104220
Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 90 Years
SexAll
Healthy volunteersAccepted
ConditionNon-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity, Metabolically Normal Obesity, Obesity
Full registry criteria
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: * 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
Treatments and study arms
Weight loss
Other
Bariatric surgery-induced weight loss to achieve \~20%-30% reduction in initial body weight
Primary outcomes
Insulin sensitivityBaseline
Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Washington University School of Medicine🇺🇸 St Louis, Missouri, United States