Nonalcoholic Fatty LiverNCT04595474
Prevalence of NAFLD and Advanced Fibrosis in Patients With Type 1 Diabetes
An observational study of Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The aim of this study is to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes receiving care at Joslin clinic using noninvasive imaging and serum-based methods with the goal of identifying high-risk patients with advanced fibrosis who should be prioritized for specialty… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Fibrosis, Liver
- What is being tested?
- Transient Elastography
- Type of treatment
- Medical device
- How many people
- 533 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include subjects with type 1 diabetes receiving care at Joslin Diabetes Center. Addiotnal subjects from the broader Boston area may be recruited for the study.
Who may be able to join
- Subject is male or female
- Subject age between 18-75 years old
- Subject with an established diagnosis of T1D for at least three months prior to screening
Who cannot join
- Subject is pregnant or lactating
- Subject has an active malignancy
- 4.Subject with secondary causes of fatty liver including history of any of the following:
- Hepatitis B or C virus infection
- Wilson's disease
- Lipodystrophy
Show all 9Show fewer
- Abetalipoproteinemia
- Current or previous use of any of the following medication: amiodarone, tamoxifen, methotrexate,corticosteroids (e.g. Prednisone), or Valproate
- Male subject consuming >30 g of alcohol per day or female subject consuming >20 g of alcohol perday
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Prevalence of Nonalcoholic Fatty Liver Disease and Advanced Fibrosis in Patients With Type 1 Diabetes Using Vibration-Controlled Transient Elastography and Noninvasive Scores
The aim of this study is to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes receiving care at Joslin clinic using noninvasive imaging and serum-based methods with the goal of identifying high-risk patients with advanced fibrosis who should be prioritized for specialty referral
Read the detailed description
This is a prospective cohort, single-center, single-arm study screening adult subjects with type 1 diabetes from the Joslin Diabetes Center outpatient clinic mainly through physician referrals for NAFLD and advanced fibrosis. Subjects will undergo a one-time screening which will last for about 30 minutes.
The following procedures will be conducted during the study visit:
- Blood draw for metabolic measurements (HbA1c, lipid panel, ALT, AST, serum albumin, complete blood count-CBC)
- FibroScan Measurements (LSM and CAP)
- Anthropometric measurements (weight, height, BMI calculation, waist, and hip circumference)
- Systolic and diastolic blood pressure
Blood Draw:
Samples of blood taken during the trial for laboratory testing will include the following metabolic measurements: AST, ALT, Platelets, percentage A1C, and lipid parameters (TC, LDL, HDL, TG).
Fibroscan: Vibration controlled transient elastography (VCTE) or FibroScan® (EchoSens, Paris, France) is a simple aid to diagnose adult patients with chronic liver diseases. FibroScan provides a fast and reliable alternative to hepatic needle biopsy. In this 5-7 minute test, the investigator induces a mild amplitude shear wave into liver tissue from a small mechanical vibrator at the end of the FibroScan probe. VCTE evaluates a representative volume of the liver that is 100-fold greater than needle biopsy and the liver stiffness measurement (LSM) is expressed in kilopascals (kPa) with values >9.8 kPa being consistent with the presence of advanced fibrosis/cirrhosis. Typically, 10 successful VCTE measurements with a median interquartile range/median ration of less than 30% are needed to have a reliable LSM.
FIB-4 Index: This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:
FIB-4 = Age (years)×AST (U/L)/[PLT(109/L)×√ALT(U/L)] (Sterling, Lissen et al. 2006) FIB-4>2.67 is consistent with the presence of advanced fibrosis with 80% PPV.
NAFLD Fibrosis Score (NFS): This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:
NFS= -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).
NFS>0.676 is consistent with the presence of advanced fibrosis
Anthropometric measurements: These include weight, height, BMI calculation, waist, and hip measurements. Measurements will be done using standardized anthropometric techniques.
Follow up may be required for High-risk patients with advanced fibrosis. If patient consents, referring or treating physicians will be notified and provided with fibroscan results for possible referral to hepatologists for further evaluation and intervention.
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Fibrosis, Liver, Type 1 Diabetes, Cirrhosis, Liver
- Being tested
- Transient Elastography
- Keywords
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), Type 1 Diabetes, Screening, Advanced fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient ElastographyDevice
Transient elastography is a noninvasive imaging modality used to assess NAFLD and advanced fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | 533 adult subjects with type 1 diabetes with no secondary causes of fatty liver Receives: Device: Transient Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with NAFLD
Controlled Attenuation Parameter (CAP) will be used to define the presence of NAFLD
Measured: Baseline (one time point evaluation)
Proportion of subjects with advanced fibrosis
Transient elastography will be used to define the presence of fibrosis
Measured: Baseline (one time point evaluation)
Secondary outcomes (5)
Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS
NFS will be calculated using the following formula:
NFS= -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).
Measured: Baseline (one time point evaluation)
Proportion of subjects with advanced fibrosis per Fibrosis-4 (FIB-4) index
FIB-4 will be calculated using the following formula:
FIB-4 = Age (years)×AST (U/L)/[PLT(109/L)×√ALT(U/L)]
Measured: Baseline (one time point evaluation)
HbA1c
Association with level of diabetes control as reflected in percentage HbA1c
Measured: Baseline (one time point evaluation)
Anthropometrics
Association with BMI and waist circumference
Measured: Baseline (one time point evaluation)
Lipid profile
Association with lipid parameters (LDL, HDL, TG)
Measured: Baseline (one time point evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start14 Jan 2021
- Primary completion19 Aug 2022
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 533 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Hamdy, MD PhD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595474
- Sponsor's protocol ID
- STUDY00000092
- Status last verified
- May 2026
- First submitted
- 13 Oct 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prevalence of Nonalcoholic Fatty Liver Disease and Advanced Fibrosis in Patients With Type 1 Diabetes Using Vibration-Controlled Transient Elastography and Noninvasive Scores
- ClinicalTrials.gov ID
- NCT04595474
- Acronym / sponsor ID
- STUDY00000092
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Fibrosis, Liver, Type 1 Diabetes, Cirrhosis, Liver
- Keywords
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), Type 1 Diabetes, Screening, Advanced fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 533 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Oct 2020 (actual)
- 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 aim of this study is to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes receiving care at Joslin clinic using noninvasive imaging and serum-based methods with the goal of identifying high-risk patients with advanced fibrosis who should be prioritized for specialty referral
Detailed description
This is a prospective cohort, single-center, single-arm study screening adult subjects with type 1 diabetes from the Joslin Diabetes Center outpatient clinic mainly through physician referrals for NAFLD and advanced fibrosis. Subjects will undergo a one-time screening which will last for about 30 minutes.
The following procedures will be conducted during the study visit:
- Blood draw for metabolic measurements (HbA1c, lipid panel, ALT, AST, serum albumin, complete blood count-CBC)
- FibroScan Measurements (LSM and CAP)
- Anthropometric measurements (weight, height, BMI calculation, waist, and hip circumference)
- Systolic and diastolic blood pressure
Blood Draw:
Samples of blood taken during the trial for laboratory testing will include the following metabolic measurements: AST, ALT, Platelets, percentage A1C, and lipid parameters (TC, LDL, HDL, TG).
Fibroscan: Vibration controlled transient elastography (VCTE) or FibroScan® (EchoSens, Paris, France) is a simple aid to diagnose adult patients with chronic liver diseases. FibroScan provides a fast and reliable alternative to hepatic needle biopsy. In this 5-7 minute test, the investigator induces a mild amplitude shear wave into liver tissue from a small mechanical vibrator at the end of the FibroScan probe. VCTE evaluates a representative volume of the liver that is 100-fold greater than needle biopsy and the liver stiffness measurement (LSM) is expressed in kilopascals (kPa) with values >9.8 kPa being consistent with the presence of advanced fibrosis/cirrhosis. Typically, 10 successful VCTE measurements with a median interquartile range/median ration of less than 30% are needed to have a reliable LSM.
FIB-4 Index: This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:
FIB-4 = Age (years)×AST (U/L)/[PLT(109/L)×√ALT(U/L)] (Sterling, Lissen et al. 2006) FIB-4>2.67 is consistent with the presence of advanced fibrosis with 80% PPV.
NAFLD Fibrosis Score (NFS): This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:
NFS= -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).
NFS>0.676 is consistent with the presence of advanced fibrosis
Anthropometric measurements: These include weight, height, BMI calculation, waist, and hip measurements. Measurements will be done using standardized anthropometric techniques.
Follow up may be required for High-risk patients with advanced fibrosis. If patient consents, referring or treating physicians will be notified and provided with fibroscan results for possible referral to hepatologists for further evaluation and intervention.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: Transient Elastography533 adult subjects with type 1 diabetes with no secondary causes of fatty liver |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include subjects with type 1 diabetes receiving care at Joslin Diabetes Center. Addiotnal subjects from the broader Boston area may be recruited for the study.
Key inclusion criteria (3 listed)
- Subject is male or female
- Subject age between 18-75 years old
- Subject with an established diagnosis of T1D for at least three months prior to screening
Key exclusion criteria (9 listed)
- Subject is pregnant or lactating
- Subject has an active malignancy
- Hepatitis B or C virus infection
- Wilson's disease
- Lipodystrophy
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 |
|---|---|---|
| Transient ElastographyTransient elastography is a noninvasive imaging modality used to assess NAFLD and advanced fibrosis | Device | Study Cohort |
Primary outcome
Proportion of subjects with NAFLD
Time frame: Baseline (one time point evaluation)
Controlled Attenuation Parameter (CAP) will be used to define the presence of NAFLD
Proportion of subjects with advanced fibrosis
Time frame: Baseline (one time point evaluation)
Transient elastography will be used to define the presence of fibrosis
5 secondary outcomes
Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS
Time frame: Baseline (one time point evaluation)
Proportion of subjects with advanced fibrosis per Fibrosis-4 (FIB-4) index
Time frame: Baseline (one time point evaluation)
HbA1c
Time frame: Baseline (one time point evaluation)
Anthropometrics
Time frame: Baseline (one time point evaluation)
Lipid profile
Time frame: Baseline (one time point evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Osama Hamdy, MD PhD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by Joslin Diabetes Center 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 3 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: under way, not looking for participants, as of the sponsor's last update on 29 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of subjects with NAFLD (time frame: Baseline (one time point evaluation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.