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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lean, metabolically normal

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese, metabolically normal

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese, metabolically abnormal

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese, scheduled for bariatric surgery

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

Group Type EXPERIMENTAL

Weight loss

Intervention Type OTHER

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

Obese, scheduled for gallbladder surgery

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Weight loss

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes