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OpenTrials
Active, Not Recruiting

NCT Number: NCT01104220

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Weight loss

Other

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

Primary outcomes

  1. Insulin sensitivity

    Time frame: Baseline

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

Secondary outcomes

  1. TNF-alpha

    Time frame: Baseline

    TNF-alpha is a marker of inflammation

  2. Interleukin-6 (IL-6)

    Time frame: Baseline

    Interleukin-6 is a marker of inflammation

  3. Liver tissue inflammation

    Time frame: Baseline

    Liver immune cell content

  4. Abdominal adipose tissue inflammation

    Time frame: Baseline only in participants scheduled for bariatric surgery

    Subcutaneous, omental and transverse mesocolic adipose tissue

  5. Abdominal adipose tissue inflammation

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

    Subcutaneous and omental adipose tissue

  6. Upper vs lower adipose tissue inflammation

    Time frame: Baseline (All groups)

    Immune cell content in abdominal and femoral subcutaneous adipose tissue

  7. Exosome-mediated intercellular signaling

    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.

  8. Exosome-mediated intercellular signaling

    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

  9. Exosome-mediated intercellular signaling

    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.

  10. Change in exosome-mediated intercellular signaling

    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

  11. Hepatic PNPLA3 synthesis rate

    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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2010
Registry last updated
Oct 23, 2025

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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