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

The Washington University

Status: Active, not recruiting

Conditions: Metabolically Abnormal Obesity; Obesity; Non-alcoholic Fatty Liver Disease; Metabolically Normal Obesity; Metabolic Syndrome

Treatments: Other: Weight loss

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01104220

201102127

Details and patient eligibility

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 6 patient groups

Lean, metabolically normal

No Intervention group

Description:

Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.

Obese, metabolically normal

No Intervention group

Description:

Subjects with body mass index ≥30.0 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.

Obese, metabolically abnormal

No Intervention group

Description:

Subjects with body mass index ≥30.0 kg/m² and impaired fasting or oral glucose tolerance and increased liver fat.

Obese, scheduled for bariatric surgery

Experimental group

Description:

Subjects with a body mass index ≥35.0 kg/m² undergoing bariatric surgery

Treatment:

Other: Weight loss

Obese, scheduled for gallbladder surgery

No Intervention group

Description:

Subjects with a body mass index ≥35.0 kg/m² undergoing gallbladder surgery

Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery

No Intervention group

Description:

Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.