Non-alcoholic Fatty Liver DiseaseNCT01104220
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
A study testing Weight loss in people with Non-alcoholic Fatty Liver Disease and Metabolic Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity
- What is being tested?
- Weight loss
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 7 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- medications that might confound the study results
- pregnancy or lactation
- exercise >2 h/week
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed 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.
- Conditions
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity, Metabolically Normal Obesity, Obesity
- Being tested
- Weight loss
- Keywords
- NAFLD, Obesity, Metabolic syndrome
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossOther
Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion
Measured: Baseline
Secondary outcomes (11)
TNF-alpha
TNF-alpha is a marker of inflammation
Measured: Baseline
Interleukin-6 (IL-6)
Interleukin-6 is a marker of inflammation
Measured: Baseline
Liver tissue inflammation
Liver immune cell content
Measured: Baseline
Abdominal adipose tissue inflammation
Subcutaneous, omental and transverse mesocolic adipose tissue
Measured: Baseline only in participants scheduled for bariatric surgery
Abdominal adipose tissue inflammation
Subcutaneous and omental adipose tissue
Measured: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Upper vs lower adipose tissue inflammation
Immune cell content in abdominal and femoral subcutaneous adipose tissue
Measured: Baseline (All groups)
Exosome-mediated intercellular signaling
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.
Measured: Baseline only in participants scheduled for bariatric surgery
Exosome-mediated intercellular signaling
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood, subcutaneous and omental adipose tissue
Measured: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Exosome-mediated intercellular signaling
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and abdominal and femoral subcutaneous adipose tissue.
Measured: Baseline only in all participants
Change in exosome-mediated intercellular signaling
Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and adipose tissue
Measured: Before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery
Hepatic PNPLA3 synthesis rate
Synthesis rates assessed by stable isotope techniques in the fasted vs the fed states
Measured: Baseline only in people scheduled for gallbladder or bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion7 Dec 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104220
- Sponsor's protocol ID
- 201102127
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2010
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31004409
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT01104220
- Acronym / sponsor ID
- 201102127
- Conditions
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Metabolically Abnormal Obesity, Metabolically Normal Obesity, Obesity
- Keywords
- NAFLD, Obesity, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2010 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Weight lossSubjects with a body mass index ≥35.0 kg/m² undergoing bariatric surgery |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossBariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight | Other | Obese, scheduled for bariatric surgery |
Primary outcome
Insulin sensitivity
Time frame: Baseline
Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion
11 secondary outcomes
TNF-alpha
Time frame: Baseline
Interleukin-6 (IL-6)
Time frame: Baseline
Liver tissue inflammation
Time frame: Baseline
Abdominal adipose tissue inflammation
Time frame: Baseline only in participants scheduled for bariatric surgery
Abdominal adipose tissue inflammation
Time frame: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Upper vs lower adipose tissue inflammation
Time frame: Baseline (All groups)
Exosome-mediated intercellular signaling
Time frame: Baseline only in participants scheduled for bariatric surgery
Exosome-mediated intercellular signaling
Time frame: Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery
Exosome-mediated intercellular signaling
Time frame: Baseline only in all participants
Change in exosome-mediated intercellular signaling
Time frame: Before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery
Hepatic PNPLA3 synthesis rate
Time frame: Baseline only in people scheduled for gallbladder or bariatric surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 31004409Yoshino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Non-alcoholic Fatty Liver Disease and Metabolic Syndrome, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.