NCT04595474

Brief 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 referral

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

October 13, 2020

Last Update Submit

August 28, 2025

Conditions

Nonalcoholic Fatty LiverNonalcoholic SteatohepatitisFibrosis, LiverType 1 DiabetesCirrhosis, Liver

Keywords

Nonalcoholic fatty liver disease (NAFLD)Nonalcoholic steatohepatitis (NASH)Type 1 DiabetesScreeningAdvanced fibrosis

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with NAFLD

    Controlled Attenuation Parameter (CAP) will be used to define the presence of NAFLD

    Baseline (one time point evaluation)

  • Proportion of subjects with advanced fibrosis

    Transient elastography will be used to define the presence of fibrosis

    Baseline (one time point evaluation)

Secondary Outcomes (5)

  • Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS

    Baseline (one time point evaluation)

  • Proportion of subjects with advanced fibrosis per Fibrosis-4 (FIB-4) index

    Baseline (one time point evaluation)

  • HbA1c

    Baseline (one time point evaluation)

  • Anthropometrics

    Baseline (one time point evaluation)

  • Lipid profile

    Baseline (one time point evaluation)

Study Arms (1)

Study Cohort

533 adult subjects with type 1 diabetes with no secondary causes of fatty liver

Device: Transient Elastography

Interventions

Transient ElastographyDEVICE

Transient elastography is a noninvasive imaging modality used to assess NAFLD and advanced fibrosis

Study Cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject is pregnant or lactating
  • Subject has an active malignancy
  • Subject with secondary causes of fatty liver including history of any of the following:
  • Hepatitis B or C virus infection
  • Wilson's disease
  • Lipodystrophy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseLiver CirrhosisDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Osama Hamdy, MD PhD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

January 14, 2021

Primary Completion

August 19, 2022

Study Completion

December 30, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)