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

NCT01104220 | Active Not Recruiting

• 1 other identifier: 201102127
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NAFLD; Obesity; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion

  Baseline

Secondary Outcomes (11)

• TNF-alpha

  Baseline

• Interleukin-6 (IL-6)

  Baseline

• Liver tissue inflammation

  Baseline

• Abdominal adipose tissue inflammation

  Baseline only in participants scheduled for bariatric surgery

• Abdominal adipose tissue inflammation

  Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery

Study Arms (6)

Lean, metabolically normal

NO INTERVENTION

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

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

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

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

Other: Weight loss

Obese, scheduled for gallbladder surgery

NO INTERVENTION

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

Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery

NO INTERVENTION

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

Interventions

Weight loss OTHER

Bariatric surgery-induced weight loss to achieve \~20%-30% reduction in initial body weight

Obese, scheduled for bariatric surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pfizer: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 31004409 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Klein, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)