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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Joslin Diabetes Center
- Enrollment
- 533
- Locations
- 2
- Primary Endpoint
- Proportion of subjects with NAFLD
Study Overview
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
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Anthropometrics(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))
- Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS(Baseline (one time point evaluation))
- Lipid profile(Baseline (one time point evaluation))